Pharmacovigilance Services Assoc Manager

Job Description:

Responsibilities

•  Participate in KOM, project planning/strategy making meeting.
•  Ensuring the aggregate reports and RMP documents are medically relevant, complete, consistent and accurate.
•  Providing inputs/insights from review of aggregated and RMP data aligned to client’s processes(s) and SOPs.
•  Addresses all previous Health authority comments and adhoc requests received from Health authority.
•  Review and provide any noteworthy cases & published studies including pregnancy registries.
•  Discuss and provide medical analysis for all relevant sections of AR and RMP
•  To provide the conclusion regarding the current safety profile of the product.
•  Address all medical queries/comments raised by the Client.
•  Perform QC of all the assigned aggregate reports and RMP documents.
•  Complete all trainings, assigned by internally or client on respective LMS within due date.
•  Responsible for knowledge sharing, coaching, review and providing feedback of reports medically analyzed by the mentees.
•  Notify critical and major deviations (referred, as Quality Issues) within one business days, and minor deviations within three business days to Accenture Quality Management team. Ensure to meet all SLAs and KPIs.
•  Incorporate comments from Client (or external) stakeholders into the draft RMP/ associated documents and seek clarification where applicable.

Qualification & Experience

• Qualifications:MBBS/MD
• Years of Experience:3 to 14 years