Competency Areas for Pharmacovigilance Professionals

                                 

A competency profile defines the competencies required to fulfil a particular role. Competencies are the measurable or observable knowledge, skills, abilities, and behaviours critical for successful job performance. Technical staff/resources in pharmacovigilance domain are competent and experienced in a wide range of scientific, healthcare, life sciences and pharmacy disciplines and areas of medicine, at graduate and post-graduate level. The core competencies for drug safety professionals are a set of skills applicable to the broad field of pharmacovigilance.

Level 1 core competencies apply to entry level drug safety professionals, i.e. new drug safety associates with non-managerial positions.

Level 2 core competencies apply to advanced and senior level drug safety associates, supervisors and managers.

Level 3 core competencies apply to associate directors, directors, and other drug safety department or organization leaders.

Qualities in working professionals in the field of pharmacovigilance:

§  Knowledge of how drugs, devices, and biologics are developed and regulated.

§  Knowledge of relevant pharmacovigilance information sources.

§  Encompass knowledge of scientific concepts related to the design and analysis of clinical trials.

• Effective understanding and use of the principles for data capture, storage, interpretation searching and retrieval.

§  Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database.

§  Computer application proficiency (MS Word, MS Excel, MS PowerPoint, web-based) for access and data entry of safety information.

Abilities and skills:

§  Professionals should have thorough understanding of clinical, biomedical and scientific reports about pharmaceutical products.

§  Accurately evaluates cases for validity and consistency, document cases according to procedures, accurately codes product-safety information and product-quality complaints.

§  Appropriately assesses case severity in order to prioritize follow-up.

§  They should be skilled to address important benefit-risk ratio associated with drugs. They must make informed decisions after finding the relevant facts. They should cater valuable contribution in business continuity plans.

§  Reviews data against source documents and submits data to regulatory in a timely manner.

§  Properly assesses submission eligibility on a case-by-case basis as per the regulations.

§  Diligently prepares and checks required documentation.

§  Identifies appropriate regulatory agency directions and makes case referrals.

§  Carefully reviews and documents regulatory agency requests.

§  Prepares clear periodic reports.

§  Should have good English writing skills.

§  Recommends action based on identified risks.

§  Helps draft safety-profile assessment reports.

§  Files case reports according to appropriate archiving practices.

§  Understand study management and GCP (good clinical practice) compliance, GPV (Good pharmacovigilance practice) modules safety management (adverse event identification and reporting, post market surveillance, and pharmacovigilance), and handling of investigational product.

§  Understanding the literature review/screening, MedDRA coding and writing risk management plans.

§  Safety services require availability of sufficient talent with significant expertise (e.g., writing periodic safety update reports and performing signal detection and analysis, running patient registries as part of Risk Management Plans).

§  Staff that already has product expertise and familiarity with issues such as product recalls and accurate coding of commonly reported events can implement and assess better risk management activities.

Industrial and Regulations exposure:

§  Writing is another of those advanced skills which every pharmacovigilance professional is expected to have. Working professionals should have clear and effective communication skills (reading and writing both) to readily exchange safety information between sponsor and regulators.

§  People in this domain should have knowledge of the business and of the pharmaceutical industry.

§  Understanding of organisation structure, responsibilities and resources.

§  They need to have capability to understand NHS, regulatory authorities, government schemes/policies concerning public health. Capable of assessment of risk management plans, post authorisation safety studies, periodic safety update reports and safety referrals.

§  Signal management (including data monitoring in EudraVigilance, signal validation/confirmation and evaluation of confirmed signals) and provision of advice on confirmation and quantification of risk and on regulatory options for managing risk.

Competencies:

§  Ability to make sound judgments and properly assess situations.

§  Ability to build relationships of trust and demonstrate professional ethics.

§  To assess various situations and develop appropriate solutions.

§  Play advisory role to assist concerned resources in pharmacovigilance matters.

Understanding of legal and related issues:   

§  European and Global PV Regulations

§  Knowledge of 21 CFR Rules

§  Pharmacovigilance regulations of different countries

§  Data Protection legislation

§  Confidentiality Agreements & Contractual Agreements

§  Copyright

§  Audits & Inspections

§  Understanding of CAPA’s (Corrective action and preventive plans), (RCA) root cause analysis and deviation memos exercised during any sort of deviation in pharmacovigilance processes. 

Ethics:

§  Working professionals should have good professional judgement to ethical issues. Professional persons in health care delivery fields (including those working in the public schools) have legal and ethical responsibilities to safeguard the confidentiality of information regarding the clients in their care.

§  Data and the personal identities of individual participants in research studies must be kept confidential. The ethical duty of confidentiality is essential to the trust relationship between patient and physician, and to the integrity of the research project.

§  Approved documents are stored on an intranet which ensures that documents are legible and readily identifiable.

§  Written records have a durability and reproducibility distinct from spoken information; Breaches of confidentiality can occur as a result of the way records are created, stored, or transmitted.

Management of Workload:

§  Induction training for organisation and project specific training for new recruits are planned. Attending conferences and external training programs; taking part in in-house training sessions and meetings.

§  Professionals are skilled in prioritising, planning and organising work with the appropriate sense of urgency based on regulatory requirements and business needs.

§  Processes adverse-event case reports and conducts follow-up; notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies; reviews scientific literature and bibliographic sources; helps draft and manage periodic safety-update reports; evaluates safety profiles; ensures document filing and archiving.

§  The safety database management system has been customised for use. The workflow module facilitates the processing and submission of cases in line with legislative timelines. The database is fully searchable through use of a query module which incorporates standardised MedDRA queries.

§  Basic knowledge of drug safety sciences medical terminology, pharmacology, or clinical background, narrative writing, assessing expectedness of adverse event, assessing causality assessment,

§  Safety Surveillance services collaborates with clients to provide signal detection, (for cases and signals) and evaluation work to monitor and track global product compliance changes that might have an impact on labelling requirements or necessitate a change to the safety profile of the product.

§  Should be skilled in creation and maintenance of risk evaluation mitigation strategies (REMS) and risk management plans (RMPs).

Personal skills and proactivness:

§  Autonomy and a sense of responsibility.

§  Analytical and synthesis skills.

§  Ability to use simple language based on target audience.

§  Ability of listening actively.

§  Ability to work on multiple projects simultaneously.

§  Ability to work as part of a team.

§  Ability to keep tight deadlines and work under pressure.

§  Ability to inspire confidence and mutual respect.

§  Excellent communication skills with different internal and external stakeholders.

§  Fluency in English (spoken and written).

§  Scientific expertise, Versatility.

§  Meticulousness and attention to detail.

§  Planning skills and organized work habits.

Accountability:

§  Professionals should be trained in front of aligning with compliance, good clinical practices (GCP), good pharmacovigilance practices (GPV) and standards set by regulatory bodies.

§  Compliant with standard operating procedures (SOP’s) and company policies. Ability to follow written documentation in support of pharmacovigilance activities, including standard operating procedures (SOPs), safety management plans and working instructions.

§  Monitors pharmacovigilance procedures according to contracts, procedures, regulations, and directives.

§  Creates or adapts pharmacovigilance procedures based on overall or business-partner procedures and prevailing regulations.

§  Archives documents according to prevailing standards.

Goal of continuous development:

§  To contribute towards developing and improving knowledge and skills.

§  Keeping abreast on current legislations, moves and development in field of pharmacovigilance. Identifying and implementing improvements in ways of working - for self and for team/department.

§  With experience, depending on interests and training, pharmacovigilance specialists can aspire to, among other positions, the following: Senior Specialist, Project Leader, Manager, Director, Consultant, Trainer or Educator.

References:

1.      Pharmaceutical information and Pharmacovigilance association Accessed from http://www.pipaonline.org/Pharmacovigilance-Competencies on 24-Oct-2015.

2.      Report to the European Commission on Pharmacovigilance audits carried out in the Irish Medicines Board in Ireland from 21-SEP- 2012 to 20-SEP-2013 Accessed from https://www.hpra.ie/docs/default-source/publications-forms/corporate-policy-documents/ie_summary-of-pharmacovigilance-system-audit-report-results_2013_final-(1).pdf?sfvrsn=2 on 27-Oct-2015.

3.      Core competencies for drug safety/Pharmacovigilance Accessed from https://cdr.lib.unc.edu/indexablecontent/uuid:540d39d8-2d71-4f7a-af0a-c3863ee01dcb on 27-OCT-2015.

4.       Pharmacovigilance specialist Accessed from http://www.pharmabio.qc.ca/content/documents/pdf/R%C3%A9f.Comp%C3%A9tences%20Anglais/Pharmacovigilance%20Specialist.pdf on 28-OCT-2015.

PV services outsourcing trends

Drug safety has moved into the media spotlight and now more than ever it is essential that patient safety is seen to be of utmost importance to regulators as well as pharmaceutical companies. Outsourcing in the pharmaceutical market has grown vastly over the last 10 years, with PV market estimated to reach $5billion in 2019, at a Compound Annual Growth Rate (CAGR) of 12.9% from 2013 to 2019.It has become almost standard practice among multinational companies to develop global sourcing programs. The outsourcing of pharmacovigilance tasks provides a flexible solution to the ever changing demands of running a specialist pharmacovigilance team. Duties usually be performed in-house are contracted to a dedicated service provider, whether it is on a full service, partial or project basis. The trend seen in drug safety services has largely paralleled the trends seen in the clinical research and product development services.

When Outsourcing helps?

·         When we need to have short term additional resources.

·         When we need to have readymade troop of skilled and trained resources.

·         When we need the flexibility to respond to varying workloads.

·         Outsourcing approach of ‘pay as you go’ allows you to respond fully to regulatory obligations, without the need of retaining a full pharmacovigilance team on the payroll.

·         The benefits of outsourcing include reduced costs due to less effort needed for staff recruitment, management and training. With stricter regulatory requirements, the hiring of experienced safety personnel has become highly competitive.

What services can be outsourced?

Company size, the size of the pharmacovigilance department and existing license or development partnerships influence outsourcing decisions. It is possible to outsource an entire pharmacovigilance (end to end) or medical information department or just individual elements, depending on your requirements. 

Recent Trends?

The range of contracted services is determined by the type of safety service providers, including individual consultants, specialty Clinical Research Organizations (CROs), large, full-service CROs and global service providers under the umbrella of business process outsourcing (BPO). Life science companies, CRO’s, KPO’s, and BPO’s shifted for doing this business. These companies come up with robust technology and mature processes to effectively address risks and concerns associated with delegating responsibility to service providers. The negotiations between the pharmaceutical company and the regulatory authorities on the risk management program had been unsuccessful over several years so the pressure has increased of late, in order to comply with evolving regulations worldwide. Regulatory observation along the entire product life cycle has seen a substantial increase, with all areas of the business being affected.

Examples of outsourcing consultation trends include:

·         Full PV service outsourcing (ICSR management & reporting of cases).

a.     Small biotech companies typically have no drug safety department and routinely

Outsource all safety services including the safety database.

b.     Mid-sized pharma companies generally have the knowledge and resources to cater

to the demands of the global pharmacovigilance environment. They face challenges to meet fluctuating resource needs associated with a changing product development.

c.     Large pharma companies have comprehensive expert pharmacovigilance

departments with global infrastructure and databases.

·         Case processing (Regulators requested an active surveillance study to detect

rare and serious adverse events for risk minimization).

·         Literature screening (Usually provide flexible end-to-end literature search and review solutions that assist companies and individuals to meet their regulatory goals).

a.     Literature review help users to stay updated in their research.

b.     Provides complete picture of today’s global clinical research in clinical medicine which is enabled by broad coverage with numerous access point, extensive search capabilities and coverage of immense data.

c.     Save research time by providing one source for variety of research data including abstracts, author’s name, contact details and information per bibliographic record than in other resources.

·         Signal detection/ benefits risk assessment (Contracted experts are external, they can provide an unbiased view, may have special value in decision making process involved in signal detection and risk management activities required for the drug.

·         MedDRA coding and writing risk management plans.

·         Aggregate reporting(PSURs/PADERs/PBRERs/DSURs)

a.     Periodic benefit/risk evaluation reports (PBRERs)

b.     Periodic safety update reports (PSURs)

c.     Periodic adverse drug experience reports (PADERs)

d.     Summary bridging reports

e.     Developmental safety update reports (DSURs)

f.      Pharmacovigilance risk assessment committee (PRAC) responses/health authority responses.

·         Aggregate reports may include following contents:

a.     Introduction

b.     Worldwide market authorisation status (dates of MAH, limits on indications if relevant to safety , treatment indications and special populations covered by the market authorisation, lack of approval, including explanation, by regulatory authorities, trade name(s), withdrawal by the company of a licence application submission if related to safety or efficacy, dates of launch when known.

c.     Update of regulatory authority (MAH actions taken for safety issues). The safety related reasons that led to these actions should be described and documentation appended when appropriate; any communication with the health profession (e.g., Dear physician letters) as a result of such action should also be described with copies appended.

d.     Changes to the RSI’s (reference safety information). It should be numbered, dated and appended to the PSUR and include the date of last revision. The revised labelling document should be used as the reference for the next report and the next period.

e.     Patient exposure (An estimation of accurate patient exposure should cover the same period as

the interim safety data).

f.      Presentation of individual case histories: Case presented as line listing, the line listing(s) should include each patient only once regardless of how many adverse event/reaction terms are reported for the case. If there is more than one event/reaction, they should all be mentioned but the case should be listed under the most serious ADR (sign, symptom or diagnosis), as judged by the MAH. An aggregate summary for each of the line listings should usually be presented.

g.     MAH’s Analysis of Individual Case Histories: This section may be used for brief comments on the data concerning individual cases. Discussions can include: serious or unanticipated findings (their nature, medical significance, mechanism, reporting frequency, etc.). The focus here should be on individual case discussion and should not be confused with the global assessment in the overall Safety Evaluation.

h.     Studies: All completed studies (non-clinical, clinical, and epidemiological) yielding safety information with potential impact on product information, studies specifically planned or in progress, and published studies that address safety issues, should be discussed.

i.      Overall safety information: A change in characteristics of listed reactions, e.g. severity, outcome, target population. Serious unlisted reactions, Non-Serious unlisted reactions. An increased reporting frequency of listed reactions. Drug abuse/misuse/overdose/interactions. Pregnancy, breastfeeding related safety concerns. Effects on vulnerable patients.

j.      Conclusion: indicate which safety data do not remain in accord with the previous cumulative

experience, and with the reference safety information (CCSI), specify and justify any action recommended or initiated.

·         Electronic reporting set up (By E2B format).

·         Contractual agreement production and maintenance

·         Risk management planning and services.

·         Due diligence support activities (The due diligence should be supplemented with data on the tenure of the staff and management team).

·         Provide insight and overview of global regulations.

·         PV Training (The sponsor drug safety team provided initial training to the CRO staff at the beginning of the relationship, the CRO is responsible for training new staff (train-the-trainer principle).

·         Quality compliance training and review (Reducing costs through low-cost or off-shore outsourcing results in quality issues and regulatory non-compliance and deviations. It is pertinent to maintain the necessary oversight and engagement with the outsourcing partners or the vendors).

·         Audit and inspection readiness and preparation. (A track record of regulatory compliance and low non-conformity rates usually indicates a robust quality management system. Audits during the cooperation either by in-house staff or an external auditor are the best tools to reconfirm that the provider meets quality standards and implements adjustments in a changed regulatory environment.

·         Clinical safety assessment (Whether you are seeking an experienced QPPV (Qualified Person) service only, LPVRP (Local Pharmacovigilance Responsible Person) service, report writing services or an entire team, service providers are able to provide subject matter expertise for matters pertaining to complex global pharmacovigilance and Medical Information regulations, expertise which may not be readily available in house). Most countries have requirement of LPVRP/QPPV. If you are exporting your drugs to any international market, it is critical to have their respective supports. Regulators prefer dealing with senior professionals experienced in pharmacovigilance. Regulators prefer having a single point of contact to address their queries and concerns. It is helpful if these are in charge of the entire pharmacovigilance operations in their region. Should be 24×7 available. The role of QPPV and/or the deputy can be outsourced, however this must form part of a formal agreement which will have clear definitions of the responsibilities of each party, moreover confidentiality must be maintained.

·         A QPPV has a central role focused on ensuring the company is meeting all of its PV responsibilities and ultimately the safety of the public using the medicine is maximised.

·         Labelling documents/ RSI’s Updating revision (CCDS/CCSI/PIL/SPC assessments)

·         SOP writing/updating/ Training (SOPs are important and can impact cost, adherence to the

sponsor’s SOPs can be advantageous. Sponsor’s SOPs, user manual and entry/coding conventions).

Conclusion:

Outsourcing pharmacovigilance activities is a standard business practice in a rapidly expanding market segment. It can be successful provided:

a.     The service provider has the qualification for the pharmacovigilance services.

b.    Contractual agreement includes well defined responsibilities.

c.     Transparency maintained at project start.

References:

1.      Pharmaceutical information and Pharmacovigilance association retrieved from http://www.pipaonline.org/Pharmacovigilance-Competencies on 24-Oct-2015.

2.      Report to the European Commission on Pharmacovigilance audits carried out in the Irish Medicines Board in Ireland from 21-SEP- 2012 to 20-SEP-2013 retrieved from

3. https://www.hpra.ie/docs/default-source/publications-forms/corporate-policy-documents/ie_summary-of-pharmacovigilance-system-audit-report-results_2013_final-(1).pdf?sfvrsn=2 on 27-Oct-2015.

3.      http://www.asha.org/Practice/ethics/Confidentiality/

4.      https://cdr.lib.unc.edu/indexablecontent/uuid:540d39d8-2d71-4f7a-af0a-c3863ee01dcb

5.     http://www.pharmabio.qc.ca/content/documents/pdf/R%C3%A9f.Comp%C3%A9tences%20Anglais/Pharmacovigilance%20Specialist.pdf

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