What are the responsibilities and job description for the Senior Director Pharmacovigilance position at Meet Life Sciences?

Senior Director of Pharmacovigilance (PV) – Summary :

Company Overview :

Key Responsibilities :

Evaluate and assess adverse event (AE) reports for safety issues.

Manage PV vendors and ensure compliance.

Act as Subject Matter Expert (SME) for Individual Case Safety Report (ICSR) processing.

Ensure AE reporting complies with global regulations (FDA, EMA, ICH).

Update and create SOPs; lead process improvement initiatives.

Collaborate with departments and partners on drug safety data exchange.

Lead training on AE and product complaints for internal teams and vendors.

Qualifications :

Education : Bachelor’s in science / health-related field; advanced degrees are a plus.

Experience : 10 years in Pharmacovigilance, Drug Safety, or Risk Management.

Knowledge : Strong understanding of global PV regulations (e.g., US CFR, EMA, ICH).

Technical Skills : Proficiency with safety databases (e.g., Oracle Argus, ArisGlobal).

Communication : Strong cross-functional collaboration, leadership, and interpersonal skills.

Ideal Candidate :

Extensive experience in PV, with expertise in global regulations and safety databases.

Strong leadership and ability to drive process improvements.

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