About this role
This role provides executive leadership and oversight for Clinical Safety and Risk Management (CSRM) globally across the product life cycle. The Vice President ensures patient safety through safety monitoring, risk management planning, and accurate safety strategy and communications for regulatory and worldwide materials.
Key Responsibilities
- Maintain medical safety oversight of safety profiles and safety communications for marketed and investigational products
- Ensure appropriate actions in response to emerging safety concerns
- Serve on governance and oversight committees and teams
- Lead and oversee CSRM efforts globally throughout the product life cycle
- Vice Chair, Safety Review Committee (SRC) and Core Member of the GCS&PV Leadership Team
Technical Overview
The role focuses on global pharmacovigilance and safety science deliverables rather than software engineering, including governance and oversight of safety data assessment from clinical trials and post-approval. It also partners with IT to ensure appropriate pharmacovigilance database and system operations supporting departmental needs.
Ideal Candidate
The ideal candidate is an experienced safety physician or medical safety leader who has led Clinical Safety and Risk Management (CSRM) within a Global Clinical Safety & Pharmacovigilance (GCS&PV) organization. They have deep ownership of pharmacovigilance and risk management across the product life cycle, including governance leadership on the Safety Review Committee (SRC) and participation in Late Development Review Committee (LDRC) meetings.
Must-Have Skills
Clinical Safety and Risk Management (CSRM) leadershipMedical safety oversight of safety profiles for marketed and investigational medicinal productsAccountability for proactively defining safety profile and developing effective risk management plansVice ChairSafety Review Committee (SRC)Core Member of the GCS&PV Leadership TeamLeadership and oversight of CSRM efforts globally throughout the product life cycle
Tools & Platforms
Pharmacovigilance databases (unspecified)Regulatory submission dossier systems (unspecified)Worldwide package circulars (documentation)
Required Skills
Clinical Safety and Risk Management (CSRM)Global Clinical Safety & Pharmacovigilance (GCS&PV)pharmacovigilancerisk management planningsafety monitoringSafety Review Committee (SRC)Late Development Review Committee (LDRC)Product Development Teams (PDTs)safety strategy for regulatory submission dossierspackage circularsEU PV legislationQuality control proceduresStandard operating procedures (SOPs)database operations
Hard Skills
Clinical Safety and Risk Management (CSRM)Global Clinical Safety & Pharmacovigilance (GCS&PV)Safety analysisRisk management planningSafety monitoringPharmacovigilanceMedical Safety ScienceRisk Management and Safety Teams (RMSTs)Safety Review Committee (SRC)Late Development Review Committee (LDRC)Safety strategy for regulatory submission dossiersRisk communicationProduct Development Teams (PDTs)Safety data assessment from clinical trialsSafety information in worldwide package circularsGlobal PV system governanceQuality control proceduresStandard operating procedures (SOPs)Database operations and enhancementsEU PV legislationDue diligenceAcquisition support
Soft Skills
Medical safety leadershipCross-functional collaborationStrategic thinkingExecutive communicationLeadership and oversightStakeholder managementGovernance participationProactive issue managementRisk escalation mindsetTeam supervision and accountability
Keywords for Your Resume
Vice PresidentClinical Safety & Risk ManagementHead of Clinical Safety and Risk ManagementClinical Safety and Risk Management (CSRM)Global Clinical Safety & Pharmacovigilance (GCS&PV)Safety physicianRisk Management and Safety Teams (RMSTs)Safety Review Committee (SRC)Late Development Review Committee (LDRC)Product Development Teams (PDTs)pharmacovigilancerisk management planningsafety monitoringsafety profilerisk communicationsafety strategy for regulatory submission dossierspackage circularsEU PV legislationdatabase operationsstandard operating procedures (SOPs)Quality control proceduresSafety monitoringregulatory submission dossiers
Deal Breakers
Must demonstrate leadership/accountability for Clinical Safety and Risk Management (CSRM) within Global Clinical Safety & Pharmacovigilance (GCS&PV), Must have experience with safety governance such as Safety Review Committee (SRC)
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