Principal Scientist
1 week ago
Key Responsibilities
- Ensures the accurate and timely evaluation of safety signals for assigned products, providing clear and concise conclusions in regulatory documents.
- Contributes to the development of Risk Management Plans (RMPs) and Risk Tables for designated products, collaborating with senior personnel.
- Authors and reviews regulatory periodic reports and associated documentation, adhering to agreed processes and timelines.
- Prioritizes tasks and manages time effectively to meet multiple deadlines, demonstrating attention to detail and quality.
About the Role
- Builds and maintains effective working relationships with line functions to address safety issues.
- Supports safety governance and cross-functional teams to detect and address product safety issues, implementing risk-reduction strategies in clinical study protocols and product labeling.
- Mentors junior colleagues, contributing to the evaluation of their activities and providing knowledge and skills guidance.
Requirements
- Health Sciences or Health Care Professional degree required, with advanced degree preferred.
- 10-13 years of pharmacovigilance experience in Safety Evaluation and Risk Management, encompassing clinical development and post-marketing activities.
- Knowledge of international pharmacovigilance requirements and drug development processes.
Scope of Accountability
- Safety signal detection, assessment, and risk management, with potential to chair Safety Review Teams.
- Provides medical/scientific knowledge in safety evaluation and risk management of Global pharma company products.
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