Sofiya Ansari

Driven and resourceful Pharmacovigilance Quality & Audit Lead with over 4 years of experience in reporting adverse events, maintaining records, sharing reconciliation reports, performing quality reviews, and conducting mock calls. Experienced in formulating and executing standard operating procedures and corrective action plans.

Pharmacovigilance, Quality and Audit Lead at HEALTH CARE AT HOME INDIA, PVT LTD (2023-08 – 2024-07)

• Adverse event reporting, source data collection, verification, and reconciliation.
• Sample call quality checks and providing feedback.
• Custodian of Adverse Event SOP and Tracker.
• Conducting induction and refresher training.
• Maintaining exceptional reports and CRM document hygiene.
• Approving patient enrolment and preparing audit parameter reports.

Pharmacovigilance Associate & Quality reviewer at WELLTHY THERAPEUTICS (2021-01 – 2023-04)

• Perform Quality reviews of calls, and chats & conduct mock calls and provide feedback.
• Perform SDV reviews to identify the AE's.
• Review and share the AE forms with the partner, reconcile the reports, archive the same, and follow up on activity as requested by the client.
• Conduct training for quality parameters and for adverse event reporting.
• Support team in updating the Standard operating procedure.

Adverse event Call Transcriber at WELLTHY THERAPEUTICS (2019-12 – 2021-01)

• To transcribe the AE calls of the SDV data.
• Document the AEs identified in the call for reporting.
• Update the tracker for the AEs reported to the client.

Quality Analyst at MAHANANDA DAIRY (2018-11 – 2018-12)

Worked as an Intern for a month as a quality analyst, testing the milk & milk product samples in order to check the standard of the final product.

Bachelor's in Food Science and Nutrition – Anjuman -I- Islam's Begum Jamila Haji Haq College (2019)

HSC in Science – Maharashtra College Science, arts and Commerce (2016)

SSC – The Salvation Army High School (2014)