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.
§ 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:
