Rutuja Borawake

Process the adverse event reports from any source as per client/sponsor agreed plans.

Manage the receipt and processing of all adverse event reports reported either
spontaneously from any source or from a clinical trial. This includes, but is not limited to:
• Data entry of safety data onto adverse event database(s) and tracking systems o Review of
adverse events for completeness, accuracy, and appropriateness for expedited reporting
• Write patient narratives & code adverse events accurately using MedDRA, if applicable to
Determine lists against appropriate label (for Marketed products, if applicable) o Identifies

Manage the receipt and processing of all adverse event reports reported either
spontaneously from any source or from a clinical trial. This includes, but is not limited to:
• Data entry of safety data onto adverse event database(s) and tracking systems o Review of
adverse events for completeness, accuracy, and appropriateness for expedited reporting
• Write patient narratives & code adverse events accurately using MedDRA, if applicable to
Determine lists against appropriate label (for Marketed products, if applicable) o Identifies

Support with quality review or peer review of the processed reports
• Assist and/or complete the database reconciliation and the associated activities, as
applicable.
• Maintain study/project level documentation as per the agreed requirements, as applicable.
• Support with training of PSS staff and mentor the team as needed.
• Support with input required for monthly status reports, assist in the generation and
maintenance of the PSS metrics (if needed)
• Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work
Instructions (WI), guidance/ procedural documents and directives associated with safety
management, reporting, and pharmacovigilance.
• Assist in the preparation for client meetings and liaise with client contacts, where
appropriate
• Assist in Quality issues management and support audit and inspection preparation, as
needed.

Ensure compliance of operations with governing regulatory requirements and applicable
study/project plans and take responsibility for quality of data processed.
• Assist in the preparation of client meetings and liaise with clients where appropriate ¨ Any
other duties as assigned by management.
• The above job duties are completed by the staff as applicable, depending on the role they
are assigned to

• Enter data of safety information, including relevant medical history and laboratory into applicable global safety database in accordance with guidelines.
• Complete data entry of all relevant information from source data.
• Coding of suspects, past drugs & concomitant medications with company & WHO dictionary as applicable.
• Assess & update event labeling as per reference safety information (RSI) documents.
• Writing clinical narrative for ICSR, including but not limited to patient demographics, medical history, medical products, lab test, treatment information, clinical story of AE etc.
• Send follow-up questions & urgent queries to call centers/LSOs as applicable.