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Delivery Operations Associate Manager

Delivery Operations Associate Manager

Accenture

3 - 5 years

8 - 12 Lacs

bengaluru

Posted:1 hour ago| Platform:

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Skills Required

operations medical pharmacovigilance qc quality management lms psur mbbs pbrer compliance pader coaching project planning

Work Mode

Work from Office

Job Type

Full Time

Job Description

Skill required: Pharmacovigilance Operations - Safety Writing
Designation: Delivery Operations Associate Manager
Qualifications:MBBS/MD
Years of Experience:7 to 10 years
What would you do

Responsible for medical review of the aggregate reports (PSUR/PBRER, PADER and other AR reports) and RMP report within agreed timeframes and to a high standard of accuracy, in compliance with client’s standard operating procedures and global regulatory requirements.
What are we looking for

Hands on experience of medical review of PBRER, PSUR, RMP and other aggregate report writing.Hands on experience of medical review of PBRER, PSUR, RMP and other aggregate report writing.
Roles and 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.
QualificationMBBS,MD

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Delivery Operations Associate Manager