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Role Overview: Ensure proactive Benefit Risk Management throughout the product life cycle, tailoring global safety data to local specificities and needs.

Key Responsibilities:

Benefit Risk Management:

• Act as a safety expert in cross-functional meetings; provide training on safety aspects.

• Update and prepare Risk Management Plans (RMPs) and Local RMP Addendums.

• Implement RMPs and Urgent Safety Restrictions.

• Engage in Direct Healthcare Professional Communications (DHPCs) management and local safety signal detection.

• Input into safety sections of local protocols (Clinical Trials, Non-Interventional Studies, etc.).

• Review concepts and protocols related to data generation activities.

Aggregate Reports:

• Provide medical input for aggregate reports.

• Support local review and submission of Periodic Safety Update Reports (PSURs/DSURs).

• Maintain a list of local authorities relevant to pharmacovigilance (PV).

Safety Regulations:

• Report regulatory requirements for Marketing Authorization Holders (MAH) and study sponsors.

• Review new/revised safety regulations and notify global and regional groups.

• Implement new legislation with local impact for IPV activities.

Local Safety Compliance:

• Provide metrics insights and lead actions as needed.

• Act as Corrective Action Preventative Action (CAPA) Content Owner.

• Review procedural documents with Subject Matter Experts (SMEs).

• Conduct impact assessments and provide content for IPV PSMF contributions.

• Maintain local PSMF implementation and collaborate with local/cluster case management teams for audit readiness.

Essential Knowledge & Skills:

• Fluency in the French language and English is a must for this role

• Proven ability to organize workflow activities and manage multiple critical issues.

• Expert knowledge of Global, Regional, and Local Procedural Documents.

• Computer literacy with knowledge of relevant IT safety systems.

• Excellent verbal and written communication skills; ability to negotiate and communicate with internal and external customers.

• Ability to establish and maintain open relationships within the organization and with authorities.

• Knowledge of local and global product safety requirements.

• Excellent computer proficiency.

• Strong analytical skills to identify gaps, root causes, and develop solutions.

• Ability to work independently with minimal supervision and meet tight deadlines.

Experience:

• Experience in the pharmaceutical industry, including a pharmacovigilance (PV) responsibility role.