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Pharmacovigilance Supervisor
Pharmacovigilance SupervisorPharmaron • Franklin, NJ, US
Pharmacovigilance Supervisor

Pharmacovigilance Supervisor

Pharmaron • Franklin, NJ, US
13 hours ago
Job type
  • Full-time
Job description

Overview

Pharmacovigilance Supervisor at Pharmaron

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 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, ADCs, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit www.pharmaron.com.

Responsibilities

  • Manage PV projects independently, including communicating with clients, creating project plans, preparing study-specific Safety Management Plans and controlling project progress.
  • Solve PV project issues and maintain good communication with clients.
  • Receive safety reports from various sources, processing case reports in the safety database, raising queries, regulatory / site submissions and follow up.
  • Safety update reports (DSUR, PSUR, etc.) writing and quality control.
  • Formulate literature search strategy and conduct literature searches.
  • 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.

Qualifications

  • Bachelor\'s degree or higher in Medicine, Pharmacy, Nursing or equivalent scientific or healthcare discipline or allied life sciences.
  • Minimum of 5 years of experience in pharmacovigilance, with solid knowledge of pharmacovigilance practice.
  • Knowledge of FDA PV regulations and global regulations and guidance for clinical and post-marketing safety.
  • Experience in PV management of clinical trials.
  • Proficiency in Chinese (Mandarin / Cantonese) – speaking, reading, and writing is highly desirable to effectively communicate with clients, stakeholders, and team members, and to manage documentation in Chinese.
  • 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
  • Job Details

  • Location : New Jersey (on-site)
  • Salary : $80,000 to $100,000 per year
  • FLSA Classification : Exempt
  • Seniority level : Mid-Senior level
  • Employment type : Full-time
  • How to Apply

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

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