Job Description

Skill required:

Pharmacovigilance Operations - Safety Writing

Designation:

Delivery Operations Associate Manager

Qualifications:

MBBS/MD

Years of Experience:

7 to 10 years

About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song-- all powered by the world's largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com

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.




MBBS,MD