Head of Risk Management
Managerial · Regulatory Authority · Risk Management
Provides strategic guidance on risk-management planning documents and activities.
Also known as: Safety Risk Lead, Director of Risk Operations, Head of Risk And Compliance
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
- Provide strategic guidance to product teams during the development of risk management planning documents, provide recommendations for risk management activities including country-specific PV and risk minimization activities, as needed.
- Attend relevant safety risk management meetings.
- Perform strategic, targeted review of risk management planning documents for appropriateness of the content, compliance with the applicable template(s), and consistency with related documents.
- Maintain and share knowledge of evolving global regulatory risk management requirements.
- As appropriate, lead or participate in the provision of feedback regarding draft guidance and other regulatory initiatives to health authorities.
- Partner with other functional areas to support safety risk management initiatives.
- Identify, explore, and pursue innovative risk management opportunities through internal and external partnerships.
- Proactively identify and resolve issues related to safety risk management.
- Contribute to transparency and communication initiatives through the provision of scientifically rigorous and consistent information to promote the safe and effective use of medicines.
- Liaise with and provide technical information, advice and guidance on relevant PV matters to other regulatory colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public.
- Support external compliance monitoring with PV obligations.
- Participate at all levels (internally and externally) in the formulation and preparation of regulatory policies, guidelines, legislation, and opinions.
- Develop and promote best practices, processes, tools, and policies to ensure consistent safety risk management excellence across the organization.
- Provide leadership, motivation, encouragement, and effective management for all relevant staff.
- Develop and implement relevant training.
Overall required level: Expert.Draft competency standard for the Head of Risk Management 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 |
|---|---|
| Risk management planning (GVP Module V): RMP structure and lifecycleRef: EMA GVP Module V — Risk management systems (Rev 2) | Expert |
| Risk minimisation measures and REMSRef: EMA GVP Module XVI — Risk minimisation measures (Rev 3) | Expert |
| Benefit–risk assessment methodologyRef: ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER) | Intermediate |
| Post-authorisation safety studies (PASS/PAES)Ref: EMA GVP Module VIII — Post-authorisation safety studies (Rev 3) | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| PV policy, legislation and guideline developmentRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | Expert |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Risk planning |
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| Risk minimisation |
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| Benefit–risk |
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