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Aggregate Report Specialist

REMOTE, NJ 00000

Posted: 03/24/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 547527 Is job remote?: Yes Country: United States

Job Description

At least 4-5 years of experience in authoring of Aggregate safety reports or working on signal
detection activities, safety analyses of large complex aggregate datasets is mandatory
• Should have good understanding of the requirements of various aggregate reports (PBRERs,
PSURs, PADERs, Risk Management Plans)
• Should be able to perform and/or lead aggregate safety analysis and case level review
• Author, contribute, and coordinate the preparation of core safety deliverables
• Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met
• ARIS G or ARGUS safety database experience is preferable but not mandatory.
• First round of interview, second with the client PoC (This may be one or two
• The role reports into Associate Director, PSSA. The candidate will be working closely with client
PoCs. All work assignment will be directly from the client

*CO/NYC candidates might not be considered
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