PV Project Manager
Managerial · Industry · Project Management
Oversees and coordinates work and collaboration on PV projects.
Also known as: PV Project Director, Head of Project Management
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 and coordinate work and collaboration on PV projects.
- Prepare project scope and objectives.
- Act as the primary contact point for project-related matters.
- Maintain the project-specific responsibility assignment matrix.
- Assure that all PV staff is familiar with all involved parties and the project scope.
- Have an overview of all tasks to be delivered, including deadlines and interim milestones.
- Ensure that all the outputs are delivered in high quality and before the final deadline.
- Prepare reports and invoices, if delegated.
- Keep an oversight on all communication.
- Make sure that quality standards are met.
- Have oversight of all relevant SOPs.
- Monitor compliance results and propose corrective and preventive actions, where necessary. Prepare Deviation reports.
- Responsible for drafting procedures, manuals, work guides related to the PV project.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Has shared responsibility with corresponding leadership 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 Project 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 project and vendor managementRef: EMA GVP Module I (quality system; outsourced activities) | Expert |
| Outsourcing models and SDEA/PV agreementsRef: EMA GVP Module I; GVP Module II | Intermediate |
| Quality and compliance metrics (KPIs/KRIs)Ref: EMA GVP Module I — Pharmacovigilance systems and their quality systems | Intermediate |
| PV process and SOP landscapeRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems | Intermediate |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Expert |
| CAPA (corrective and preventive action) managementRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1) | Expert |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Delivery |
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| Oversight |
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| Coordination |
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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.
