Global Safety Manager – Pharmacovigilance

About the role

Opella is seeking a Global Safety Manager to lead scientific and safety activities across its worldwide portfolio. Reporting to the Global Pharmacovigilance Team Lead, you will ensure the ongoing safety assessment of OTC and supplement products and support risk‑management strategies.

Key responsibilities

• Provide pharmacovigilance (PV) and risk‑management expertise to internal and external stakeholders.
• Maintain up‑to‑date knowledge of product safety, regulatory guidelines, and recent literature.
• Represent PV analyses in safety governance committees, negotiations with health authorities, and external partners.
• Lead signal detection, aggregate safety data review, and proactive safety analyses.
• Develop and implement REMS, Risk Management Plans, and safety action plans, monitoring their effectiveness.
• Co‑lead benefit‑risk assessments and ensure accurate risk communication, including labeling updates.
• Support clinical trial safety, due‑diligence activities for acquisitions/divestments, and pharmacovigilance agreements.

Required profile

• Extensive experience in pharmacovigilance and product safety assessment.
• Strong understanding of international safety regulations and guidelines.
• Proven ability to communicate PV positions to cross‑functional teams and regulatory bodies.
• Experience leading safety governance committees and risk‑management initiatives.

Required skills

• Pharmacovigilance (PV) expertise
• Signal detection and analysis
• Risk Management Plans (RMP) development
• REMS creation and implementation
• Benefit‑risk assessment
• Regulatory compliance (EU, US, etc.)
• Clinical trial safety support

What we offer

• Opportunity to work with a global leader in OTC and supplement markets.
• Collaborative environment within a B Corp‑certified organization.
• Access to state‑of‑the‑art manufacturing sites and innovation centers.