Pharmacovigilance

Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements

As a subject matter expert, you would be leading the workshop discussions on configurations with concerned business leads, understand & document business requirements. Solution designing, problem solving and working closely with other leads / consultants on a project assignment would be part of core responsibilities in this role.

Masters degree in Pharmacology/ Clinical Pharmacology/ Pharmacy Practice/Clinical Research. OR Pharm.D/ MBBS/ BDS from a recognized University/Institute. 1 year experience in drug safety/ Pharmacovigilance. Indian Pharmacopoeia Commission

Case Intake, Data enter, Quality review information received pertaining to the case in the database. Refer to the Data entry conventions for any questions while entering the data.

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