Pharmacovigilance

Interfaces with various internal and external parties to implement projects, prepares Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals. Thermo Fisher Scientific

Pharmacovigilance Operations Manager at Amgen oversees the operations of the pharmacovigilance department, including the handling of adverse event reports, risk management, and safety communication. They ensure compliance with global safety regulations and guidelines. Amgen

Monitor and route incoming safety information to the appropriate project teams. Record all ICSR documentation and track cases in accordance with sponsor/customer specifications; distribute incoming mail and faxes.

The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is a plus. The role involves a hybrid work model with rotational shifts.

In this role you are required to solve routine problems, largely through precedent and referral to general guidelines

Bachelors degree in pharmacy, life sciences, or a related field. Basic understanding of pharmacovigilance principles and regulatory guidelines is desirable but not required; relevant training will be provided. ICON plc

Responsible for one or several of the following: processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information

Preferred certifications include pharmacovigilance or drug safety training from recognized industry bodies such as DIA or similar professional organizations.

Manage safety case processing, adverse event reporting, and pharmacovigilance workflows. Configure Vault objects, workflows, lifecycles, roles, and security settings.