LeadershipL.I.HS

Head of Safety

Leadership · Industry

Accountable leader for the establishment and maintenance of pharmacovigilance governance across the organisation.

Also known as: Head of Group Health and Safety, Head of Patient Safety, Director of Drug Safety

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

Ensure the establishment and maintenance of PV governance within the organisation.
Establish a clear vision, action plan, and processes to bridge PV Operations, Medical Safety, and Safety Science.
Accountable for compliance, documentation, and training of processes with ongoing assessment of continuous process improvement.
Lead the development and compliance of annual safety reports, investigator communications, product labelling, etc.
Responsible for the development of risk management, minimisation plans and strategies, and the assessment of risk for drugs in development through commercialisation.
Ensure consistency and standardisation of roles and procedures throughout the organisation.
Build the PV strategy and timelines and plan the budget for the division.
Support and facilitate communication in responding to safety questions from regulatory authorities, as well as audits and inspections with corrective action plans.
Ensure oversight and management of all outsourced or insourced PV activities, including key quality and compliance metrics.
Ensure accurate and current PV agreements and Safety Data Exchange Agreements are in place with all licence partners, vendors and third parties.

Overall required level: Expert.The Head of Safety is expected to demonstrate expert-level command of the pharmacovigilance system, safety governance, risk management and inspection readiness, together with strong leadership competencies.

Prerequisites

Mandatory prerequisites

→University degree in medicine, pharmacy, life sciences or a related field
→Substantial experience in pharmacovigilance and safety leadership

Recommendations

→Working proficiency in English
→Prior line-management experience

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 legislation and Good Pharmacovigilance Practices (GVP) overview	Expert
The PV system and Pharmacovigilance System Master File (PSMF)	Expert
Roles and responsibilities of the QPPV and the PV organisation	Expert
Quality management systems and data integrity principles	Intermediate

Role-Specific Knowledge

Topic	Level
Risk management: RMP / REMS and risk minimisation measures	Expert
Aggregate safety reporting (PBRER/PSUR, DSUR)	Expert
Signal management (detection, validation, assessment)	Expert
Audit and inspection readiness; CAPA management	Expert
Safety Data Exchange Agreements and vendor/partner oversight	Intermediate
PV budgeting, resourcing and business continuity planning	Intermediate

Knowledge · Skills · Attitude

A summary of the competency elements expected for this role.

Element	Knowledge	Skills	Attitude
Safety governance	PV system architecture Safety governance frameworks Global safety team operating models	Setting PV strategy and vision Establishing standardised processes and SOPs	Accountability for the safety of company products
Risk management strategy	Benefit–risk methodology RMP/REMS structure and lifecycle	Directing risk minimisation strategy Overseeing benefit–risk decisions	Proactive, patient-centred risk mindset
Regulatory compliance & inspections	GVP compliance obligations Inspection and audit processes	Leading inspection responses Driving corrective and preventive actions	Commitment to continuous improvement and compliance
Leadership	Budgeting and resource planning Vendor governance	Leading and developing PV teams Cross-functional stakeholder management	Integrity and business-ethics compliance

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