PV Academic Program Manager
Managerial · Academia
Oversees the development of a detailed PV academic program.
This competency standard is a working draft prepared for reviewand is not yet an official GPPC standard. Content is derived from the role’s job description and established pharmacovigilance practice, and is subject to change.
Job description
- Oversee the development of a detailed PV program. Serve as the primary reviewer/approver.
- Develop and manage integrated PV program delivery timelines and risk assessments to report the progress.
- Train PV program team members on program-specific tasks and provide a working knowledge of the program assigned.
- Work with relevant departments to verify adequate program resourcing.
- When applicable guide PV best practices, regulatory recommendations, and operational processes.
- Provide oversight and direction of PV deliverables as a PV subject matter expert, encompassing all activities throughout the duration of a project/program.
- Provide oversight and direction of PV deliverables as a PV subject matter expert, encompassing all activities throughout the duration of PV program(s).
- Responsibilities are shared with the head of the PV Academic Program in the improvement of relevant processes.
- Provide adequate support, motivation, encouragement, and effective management for all relevant staff.
- Develop and implement relevant training.
Overall required level: Expert.Draft competency standard for the PV Academic Program Manager role. As a managerial role, expert-level knowledge of the managed function and strong oversight, compliance and people-management competencies are expected. Levels are an initial proposal derived from the role's job description and typical pharmacovigilance practice, pending expert review.
Prerequisites
Mandatory prerequisites
- →University degree in medicine, pharmacy, life sciences or a related discipline
- →Relevant pharmacovigilance experience appropriate to the role
Recommendations
- →Working proficiency in English
- →Familiarity with the applicable GVP modules
Concept of levels
Knowledge for each topic is assessed on a four-level scale.
| Level | Expected knowledge |
|---|---|
| N/A | No knowledge required. |
| Basic | Elementary knowledge of the specific regulation; fundamental understanding of the terms and definitions used, a basic understanding of the concept of the regulation, a general overview of what it covers and where it can be found; passive/delegated usage of the regulation. |
| Intermediate | Very good knowledge of the specific regulation; comprehensive understanding of the terms and definitions and of the concept and context of who/when/where/why/how it applies; active usage of the regulation when required. |
| Expert | Excellent knowledge of the specific regulation; in-depth understanding of the concept and of how and why its sections should be implemented and followed, including outcomes and responsibilities for all relevant stakeholders; active usage of the regulation on a daily basis. |
Knowledge
General Knowledge
| Topic | Level |
|---|---|
| Pharmacovigilance principles and Good Pharmacovigilance Practices (GVP) overviewRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems; EU Reg (EC) 726/2004 & Dir 2001/83/EC | Expert |
| The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Expert |
| Individual case safety report (ICSR) management and regulatory reporting timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1); ICH E2B(R3) | Expert |
Role-Specific Knowledge
Includes topics derived from this role's job description.
| Topic | Level |
|---|---|
| PV curriculum and educational methodsRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Expert |
| Pharmacovigilance science and research methodology | Intermediate |
| Regulatory framework and GVP overviewRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems | Intermediate |
| Scientific writing and publication | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| Budgeting, resourcing and business continuity | Expert |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Teaching |
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| Research |
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| Dissemination |
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Get certified for this role
Certification validates prerequisites via CV screening and assesses knowledge through an online, AI-proctored examination based on the competency standard. The latest terms and requirements for every role and region are maintained by the Institute of Pharmacovigilance.
