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| Job Location | Delhi |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Engineering / Construction |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Job Description Global Pharmacovigilance and Risk Management Pharmacovigilance Specialist/Sr. Specialist Description: The Pharmacovigilance (PV) Specialist/Sr. Specialist will be responsible for post marketing and clinical trial safety activities, ensuring that Adverse Events are identified and processed in accordance with international regulations. The PV Specialist/Sr. Specialist will also work in close collaboration with vendors and affiliates to ensure that individual case reports for pre- and post-marketed products are properly produced, exchanged and submitted. Responsibilities: Provides oversight and support for external safety data processing provider ensuring high quality and compliant individual case safety report processing. Review and approve adverse event reports for pre- and post-marketed product: clarify medical issues, insure clear narratives, revise MedDRA terms, and coordinate with external vendor and internal medical personnel as needed. Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed. Respond to internal and external stakeholders on case processing queries. Represent the Pharmacovigilance department on clinical project meetings and perform clinical trial support activities relating to drug safety, as required. Inform Manager/Director of safety related issues and potential trends and or signals arising from review of pre and post marketed safety data. ,
Keyskills :
pharmacovigilancesafetycasecompliancequalityassurancedrugsafetyadverseeventsdataprocessingcaseprocessingclinicaltrialriskmeddramedicalmetricsclarifyclinicalendinfvend