Pharmacovigilance Supervisor

Position: Pharmacovigilance Supervisor

Location: New Jersey (on-site)

Salary : $80,000 to $100,000 per year

FLSA Classification : Exempt

Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects , 1,000+ CMC programmes , and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers . To learn more, visit .

Job Overview:

The PV Supervisor will be a key member of the US PV Team making appropriate processes for the project according to regulations and SOPs, and managing PV projects and performing PV work independently. This person will have strong technical expertise, will be a collaborative team player and proactive problem solver.

Additional tasks:

• Manage PV projects independently, including communicating with clients, making project plan, prepare study-specific Safety Management Plans and controlling project progress.
• Solve the problems of the PV project, and maintain good communication with clients.
• Receive safety reports from various sources, appropriately processing case reports in the safety database, raising query, regulatory/site submission and follow up.
• Safety updated report (DSUR, PSUR, etc.) writing and quality control.
• Formulate literature search strategy and conduct literature search.
• Support business bidding.
• Attend department or project meetings and provide feedback on challenges/problems or successes.
• Potentially responsible for establishing the PV team in the United States.
• Perform other duties as assigned.

What We're Looking For:

• 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.
• Proficiency in Chinese (Mandarin/Cantonese) - including speaking, reading, and writing is highly desirable to effectively communicate with clients, stakeholders, and team members, and to manage documentation and correspondence in Chinese.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative 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.

Comprehensive benefit package : As part of our commitment to your well-being, we offer a comprehensive benefits package:

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

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