Drug Safety Associate

2 weeks ago

Princeton, United States APCER Life Sciences Full time
Job DescriptionJob Description

• Book in and Triaging of ICSRs

• Perform data Entry of ICSRs in Pharmacovigilance database.

• Entering source data in the database, Coding, Narrative(s) writing, and Generate Follow-up letters.

• Generation of regulatory/partner submission reports and submission of cases.

• Send follow-up/administrative queries.

• Review of literature articles and assessment for identifying valid ICSRs.

• Compliance to project guidelines.

• Execution of Company Standard Operating Procedures.

• Builds and maintains good relationships across functional units and company affiliates.

• Maintain awareness of changes to/new regulations affecting PVG activities.

•To carry out necessary administrative duties required for the job

• Support in the preparation of aggregate reports (if applicable)

• Support in Signal detection of the ADRs with cases received from client's products (if applicable) • Submission of product information in Eudravigilance database using eXtended Eudravigilance medical product dictionary (XEVMPD) (as applicable).

• Support management in all aspects of project management for clients

• Other duties as assigned by management.

Company DescriptionAPCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.Company DescriptionAPCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.

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