Pharmacovigilance Project Management Manager/Senior Manager
Pharmaron
- Exton, PA
- Permanent
- Full-time
- Manage PV projects independently, including communicating with clients, making project plan, prepare study-specific Safety Management Plans and controlling project progress;
- Solve the problems with the PV project, and maintain good communication with clients;
- Report and communicate the details of the project process to the client;
- Communicate with PV internal team members (mainly Chinese team) in different functions, such as project management, safety reporting, medical safety, safety database, etc., to ensure all services are performed in high quality according to project requirements;
- Coordinate with US study team to ensure PV function is well collaborated with other functions;
- Support business bidding;
- Attend department meetings and provide feedback on challenges/problems or successes;
- Potentially responsible for establishing the PV project management team in the United States;
- Perform other duties as assigned.
- Bachelor's degree or other advanced degree in Medicine, Pharmacy, Nursing or equivalent Scientific or healthcare discipline or allied life sciences;
- Minimum of 5 years of experience in pharmacovigilance, good experience and understanding of pharmacovigilance;
- Knowledgeable of FDA PV regulations and relevant global regulations and guidance for clinical and post-marketing safety;
- Experience in PV management of clinical trials;
- Excellent communication skills;
- Strong time management skills with ability to manage multiple projects and timelines;
- Ability to rapidly synthesize complex issues and identify risks in a pragmatic way;
- Motivated individual with a passion for learning in a dynamic, fast-paced environment.