Monday 6 November 2017

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.


§  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. 

§  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.


§  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.

1.      Pharmaceutical information and Pharmacovigilance association Accessed from 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 on 27-Oct-2015.
3.      Core competencies for drug safety/Pharmacovigilance Accessed from on 27-OCT-2015.


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