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ManagerialM.I.PVVM
PV Vendor Manager
Managerial · Industry · Vendor Management
Determines and oversees outsourced PV tasks and manages service-provider relationships.
Draft
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
- Determine outsourcing tasks.
- Oversee tasks outsourced to service providers.
- Provide clear direction to the vendor for expected deliverables and timelines for completion.
- Provide background information and necessary interval and cumulative data for safety analysis(es) including (but not limited to) most current company core labelling and PBRER, signal source, and safety database and literature outputs.
- Resolve vendor questions and escalate issues to relevant in-house PV staff as appropriate.
- Provide regular vendor feedback to in-house PV Science Manager for inclusion into the Vendor Operational Governance Meetings.
- Review and approve vendor invoices related to outsourced PV tasks to ensure accuracy of unit charges.
- Ensure all globally sourced activities, across all geographical regions, are managed and governed in a tightly controlled and transparent manner.
- Actively participate in business initiatives related to the overall outsourcing strategy, with the responsibility to drive alignment with key transversal partners (i.e. Procurement, Legal, other Stakeholders as needed).
- Maintain a high level of strategic decision-making authority with a high financial impact.
- Support a finance division in developing sound and defensible budgets for PV.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Propose process improvements.
- 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 Vendor 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 |
| Signal management process (GVP Module IX)Ref: EMA GVP Module IX — Signal management (Rev 1) | Expert |
| Aggregate safety reports (PBRER/PSUR, DSUR)Ref: EMA GVP Module VII (PSUR); ICH E2C(R2) (PBRER); ICH E2F (DSUR) | Expert |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Expert |
| Safety database administration and configurationRef: ICH E2B(R3); EMA EudraVigilance | Expert |
| Literature monitoring and reviewRef: EMA GVP Module VI (Rev 2) — literature monitoring | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| Budgeting, resourcing and business continuity | Expert |
| Vendor governance and outsourcing oversightRef: EMA GVP Module I (outsourced activities) | Expert |
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.
