Pharmacovigilance Associate, Client Site Operations

APCER Life Sciences, Inc. is seeking a Pharmacovigilance Associate, Client Site Operations for its offices in Jersey City, NJ and Princeton, NJ.

Job Duties:

Oversee and perform the periodic reconciliation of safety report information between the drug safety database and local Pharmacovigilance representatives. Perform assigned PV related activities in accordance with Client Site Standard Operating Procedures and regulatory requirements, including oversight of Case Management Mailboxes and ICSR processing. Oversee and perform the collection and follow-up processes of adverse event (AE) reports from clinical trials and post-marketing sources. Coordinate internally and with external pharmacovigilance providers (CROs) and Business Partners on Drug Safety and Pharmacovigilance case management issues. Collaborate with PV management in investigation, root cause, corrective and preventive actions related to internal and external PV associated CAPA findings. Lead and provide safety operations support on assigned studies and support PV Inspection/Audit activities or Health Authority requests.

Education Requirement: Must have a bachelor’s degree in Dentistry, General Medicine, Pharmacy, or a related field (or foreign degree equivalent).

Experience Requirements: Six months of experience as a Pharmacovigilance Associate or related. Experience must include:

ICSR processing in Argus/ARISg including MedDRA Coding, Narrative Writing, and WHODD Coding;
Perform reconciliation oversight between clinical and safety databases;
Held primary responsibility to collect details of adverse events received by any medium including medical history, hospital records, and other essential health information;
Assessment of medical information to determine causality and seriousness of adverse events as it relates to Pharmacovigilance.

Salary range: $75,566 – $100,000. Benefits: Commuter, Medical, Dental, Vision, Life and Disability benefits, 401k, Discount and Complimentary Programs, and FSA and HSA.

Job Order number must be indicated on your response.

Please send resume to:

#J-18808-Ljbffr

APCER Life Sciences, Inc.

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Pharmacovigilance Associate, Client Site Operations