About this role
About the Role Senior Pharmacovigilance Associate will oversee the medical aspects of pharmacovigilance activities, ensuring safety of investigational drugs and contributing to safety surveillance and regulatory reporting. The role involves comprehensive medical review of ICSRs, cross-functional collaboration, and providing technical leadership within Case Management and Global Patient Safety. What You'll Do
- Provide medical review and assessment of adverse event reports from clinical trials and post-marketing sources.
- Conduct comprehensive ICSR medical reviews across all therapeutic areas with high-quality outcomes and regulatory timeline adherence.
- Collaborate with cross-functional teams to develop risk management strategies and risk minimization measures.
- Contribute to preparation of safety-related documents, including periodic safety reports and risk management plans.
- Stay abreast of emerging safety concerns and medical literature to inform decision-making and enhance safety surveillance.
- Provide technical leadership within Case Management and across Global Patient Safety. What We're Looking For
- BS degree in health-related or scientific field.
- At least 5 years of safety case processing experience.
- Exposure and hands-on experience with safety database (ARGUS preferred).
- Fluent in English with highly effective written and verbal communication skills.
- Strong clinical/diagnostic skills.
- Excellent interpersonal, organizational and negotiation skills.
- Ability to work on multiple projects and function effectively in a fast-paced matrixed environment.
- Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines.
- Ability to influence others (both cross-functionally and within the function).
- Must be amenable to work in a hybrid work setup (2x a week RTO) in Makati City. Compensation & Benefits
- Competitive salary and a range of benefits designed to support well-being and work-life balance, including various annual leave entitlements, health insurance options, retirement planning offerings, LifeWorks Global Employee Assistance Programme, life assurance, and flexible country-specific benefits.