Senior Manager Drug Safety

Key Responsibilities

• Oversee pharmacovigilance operations, including case management, submissions, reconciliations, and safety data management
• Ensure timely and compliant reporting of ICSRs to global health authorities (e.g., FDA, Health Canada, NMPA) and business partners
• Maintain ongoing compliance with global and local regulations, SOPs, and pharmacovigilance agreements
• Support audit and inspection readiness, including participation and management of follow-up actions
• Contribute to continuous improvement of pharmacovigilance quality systems through metrics, trend analysis, and feedback
• Partner cross-functionally with Regulatory Affairs, Medical Affairs, Clinical teams, IT, and Risk Management
• Cookbook pharmacovigilance activities with distributors and partners across the Americas and ROW
• Act as an escalation point for complex safety operations and compliance issues

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline
• Minimum of 5 years of pharmacovigilance experience, preferably within a global, matrixed organization
• Strong knowledge of pharmacovigivalence regulations (GVP, FDA, EMA, ICH)
• Excellent verbal and written communication skills
• Proven ability to manage competing priorities in a fast-paced environment
• Strong organizational skills with a collaborative, team-oriented mindset
• Demonstrated ability to influence stakeholders and build credibility across diverse teams