Aggregate Report Writer

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 new 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