3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in definin...

Posted 3 months ago

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Regulatory Review Advisor - Global Business Services Astrazeneca

3.0 - 5.0 years

3 - 6 Lacs

Bengaluru / Bangalore, Karnataka, India

On-site

Regulatory Reporting Compliance Ensure timely and accurate submission of regulatory reports, including Adverse Event Reports, Periodic Safety Update Reports, and other required documentation Interpret and apply global regulatory reporting requirements including those for health authorities Monitor updates to regulatory guidelines and ensure internal GBS processes align with evolving reporting standards Adverse Event and Safety Reporting Coordinate pharmacovigilance reporting activities, ensuring compliance with Good Pharmacovigilance Practices Work closely with safety teams to assess, process, and submit Individual Case Safety Reports within required timescales Assist in detection and risk a...

Posted 4 months ago

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