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 /new 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/new 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