Associate Manager/Manager, PV
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Responsibilities
- Provide scientific inputs from safety perspectives in key milestones across asset lifecycle including but not limited to the briefing book, IB, CTP, CTR, local label, ICSRs, etc.
- Lead the local RMP strategy and ensure on-time and high-quality local RMP preparation, implementation and evaluation according to local regulatory requirements.
- Generate local safety reports to Health Authority per regulations like safety summary for license renewal, fatal/cluster case investigation reports, etc.
- Review the local safety with summary per requirements and keep necessary communication with relevant stakeholders.
- Provide scientific inputs from safety perspective on the post-marketing studies (e.g. ONIS, IIS, ECR) and contribute to the development and implementation for the local PASS per local regulations
- Deliver PV knowledge or asset safety profile training to internal and external customers as needed.
- Support LPSL on maintenance of local PV system and contributes to the PV Quality system
Qualifications
- Master’s degree or above in clinical medicine
- 3+ years of pharmaceutical industry/hospital experience, pharmacovigilance or clinical development/medical affairs role is a plus
- Excellent medical judgment and scientific analysis skills
- Strong communication and influencing skills
- Cross-functional collaboration
- Strategic thinking and project management
- Risk assessment capabilities
- Good Command of English and Chinese