Pharmacovigilance Supervisor

Pharmaron • Franklin Township, NJ

7d • $80,000 - $100,000 • Onsite

About The Position

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 www.pharmaron.com . 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.

Requirements

• 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.

Nice To Haves

• Proficiency in Mandarin or Cantonese is highly desirable and would be considered a strong asset.

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 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level