Head of PV Operations
Managerial · Industry · PV Operations
Provides guidance and direction to ensure pharmacovigilance compliance at regional and country level.
Also known as: Global PV Operations Manager, Director of PV Management and Operations
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
- Responsible for providing guidance, advice and direction to ensure compliance at the regional/country level.
- Interact with Country Medical Directors, General Managers and Commercial as needed to ensure strong PV connectivity and proactively identify new programs, initiatives, strategies or risks that may impact the PV system.
- Interact with local Safety Contacts to ensure PV compliance in the regions/countries.
- Partner with senior local/regional and global roles and participate in Regional Lead team forums and governance boards to develop strategies to reduce risk to the PV system.
- Escalate non-compliance in the region as appropriate.
- Accountable for the implementation of new regulations in their region by liaising with central/regional teams and third parties.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Provide adequate support, motivation, encouragement and effective management for all relevant staff.
Overall required level: Expert.The Head of PV Operations is expected to hold expert-level knowledge of PV operational processes and compliance monitoring, with strong regional regulatory awareness and people-management competencies.
Prerequisites
Mandatory prerequisites
- →University degree in a life-science or related discipline
- →Experience in pharmacovigilance operations and compliance
Recommendations
- →Line-management experience
- →Working proficiency in English
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 |
|---|---|
| GVP and PV compliance obligations | Expert |
| ICSR management and reporting timelines | Expert |
| PV system and quality management | Intermediate |
Role-Specific Knowledge
| Topic | Level |
|---|---|
| Regional/local PV regulatory requirements | Expert |
| Compliance metrics and non-compliance escalation | Expert |
| Audit and inspection readiness | Intermediate |
| Vendor and affiliate oversight | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Operational compliance |
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| Regulatory implementation |
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| People management |
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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.
