Ankita Patil

Drug Safety Associate – MARCH-2021 – PRESENT

Position Summary: Responsible for the case processing activity of Individual Case Safety Reports (ICSRs) involving

Pharma and/or Consumer products following standard operating procedures (SOPs), internal business practices and

regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

Job Description:

● Triage and classify ICSRs ( ArisG7 database) for report type, seriousness, causality, labeling and reporting;

prioritize ICSR according to regulatory requirements.

● Completion of remaining case data entry, including narrative or auto- narrative

● Completion of risk and quality (label, approval, and manual coding).

● Clarification of unclear or illegible information from the ICSR sender (i.e. local safety officer [LSO] or Call

Center)

● Liaise with appropriate stakeholders (e.g. Global Medical Safety Operations Physicians [GMSOP],

Pharmacovigilance Physicians [PVPs]) to clarify appropriate information required for case processing

● Prioritization of incoming cases for daily workflow management

● Participation in assigned projects, including inspection/audit readiness activities and inspection and audits as

identified, including interviews and provision of requested data

Other activities relating to case processing as appropriate per case, including but not limited to:

● Single case unblinding, Serious Adverse Event (SAE) reconciliation, deviation memo preparation, deletion/

requests as needed

● Mentoring/training new hires, if required

● Responding to clients in a timely manner

Involve and support quality improvement training and initiatives.

Quality Review: (Second line reviewer)

● Perform Quality Review of ICSRs after the data entry.

● Participate in project teams to improve ICSR quality

● Document the quality review results and provide feedback to relevant team members

● Identify trends in errors and help identify training needs

Processes & Procedures:

● Comply with SOPs and Work Instructions (WI)

● Comply with clients guidance documents

● Adhere with MedDRA coding dictionary and MedDRA Points to Consider.