Position: Aggregate Report Writer

Department: Patient Safety

Location: Ahmedabad

Key Responsibilities
Prepare/update/Quality Review of Aggregate reports/ safety documents (PSURs/ DSURs/ PBRERs).
Responsible for generation of applicable line listings from safety database, literature screening for inclusion, as applicable.
Performing a literature search for aggregate reports and signal detection, as applicable
Review and Identification of case reports and AOIs from literature and regulatory sources, as applicable.
Maintain awareness of changes to regulations /recent regulations affecting pharmacovigilance activities, as applicable.
Provide inputs into the preparation of regulatory action in response to emerging safety concerns (e.g., Variations, urgent safety restrictions, and communication to patients and healthcare professionals), as applicable.
Consults/Communicates with multiple internal and external stakeholders (e.g. sponsor/ client/ medical monitor/ pharmacovigilance physician)



to decide on an action and/or additional steps to provide complete narratives to the sponsor/client, as applicable.
Participate in audits and regulatory inspections in cooperation with QA, as needed.
Review and preparation of SOPs, WIs, Guides, training materials, providing inputs to SOPs, as applicable.
Provide various quality and compliance related data/documents or any other data/documents/ evidences required for the oversight and management of pharmacovigilance activities, as applicable.
Screening and review of regulatory intelligence for identification of changes to/current regulations affecting pharmacovigilance activities. Communicate current or changed regulations to management and to relevant team members of the department to initiate any change in processes, as applicable.

Qualifications & experience required:
Life Science Graduate/Post-Graduate
1 to 6 years of experience in Aggregate Reports/Medical Safety

📌 Aggregate Report Writer Ahmedabad
🏢 COD Research
📍 Ahmedabad