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Pharmaron · 4 months ago

Pharmacovigilance Supervisor

Franklin, NJ

Full-time

Onsite

Mid, Senior Level

$80K/yr - $100K/yr

5+ years exp

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. The Pharmacovigilance Supervisor will be a key member of the US PV Team, managing PV projects independently and ensuring compliance with regulations and SOPs.

BiotechnologyChemicalPharmaceutical

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

Qualification

Pharmacovigilance experienceFDA PV regulations knowledgeClinical trial managementSafety report writingLiterature search strategyChinese proficiencyTeam collaborationProblem solving

Required

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

Preferred

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