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Pharmacovigilance Project Management Manager/Senior Manager
4 months ago
The Role:
The Pharmacovigilance (PV) Project Management Manager/Senior Manager will be a key member of the PV Project management Team in US managing PV projects independently, and making appropriate processes for the project according to regulations and SOPs. This person will have strong technical expertise, will be a collaborative team player and proactive problem solver.
Key Responsibilities:
- 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.
Desired Experience/Education and Personal Attributes:
- 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.
Why Pharmaron?
Pharmaron is a premier contract research organization that offers a broad spectrum of R&D and manufacturing service capabilities throughout the entire drug discovery, preclinical, clinical development and commercialization process. With a workforce of over 20,000 professionals and operations spanning the U.S., U.K and China.
Our Culture: You'll thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.
Your benefit package: As part of our commitment to your well-being, we offer a comprehensive benefits package, including medical, dental, and vision insurance with significant employer contributions. Planning for your future is made easier with our 401k plan and employer match. Actual compensation may vary depending on job-related factors including knowledge, skills, and experience.
EEO/AA Statement:
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
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