Aggregate Report Writer

COD Research; Ahmedabad District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

COD Research in Ahmedabad is seeking an Aggregate Report Writer to join the Patient Safety team. The role involves preparing, updating, and quality reviewing aggregate reports and safety documents (PSURs/DSURs/PBRERs) and generating line listings from safety databases.

You will perform literature screening, signal detection, and review of case reports, while staying abreast of regulatory changes and contributing to regulatory actions as needed.

Qualifications

• Life Science graduates/post-graduates with exposure to pharmacovigilance.
• Experience in aggregate reports/medical safety is preferred.
• Knowledge of PSURs/DSURs/PBRERs is advantageous.

Responsibilities

• Prepare/update/Quality Review of aggregate reports and safety documents (PSURs/DSURs/PBRERs).
• Generate applicable line listings from safety databases.
• Perform literature screening for inclusion and signal detection as applicable.
• Review and identify case reports and AOIs from literature and regulatory sources.
• Monitor regulatory changes affecting PV activities and communicate updates.

Skills

PV knowledge

Literature screening

Regulatory awareness

Stakeholder communication

Education

Bachelor's degree in Life Science

Postgraduate degree in Life Science

Job description

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