Mehak Minhas

I have worked on patient narratives as a lead for about 10 yrs and on aggregate reports. I have worked on different therapeutic areas majorly on oncology and supported pharma giants like Roche, Novartis, Johnson and Johnson etc.

Seasoned professional with over 10 years of experience in pharmacovigilance with expertise in narrative writing for clinical study reports (CSRs) for regulatory submissions. Hands on experience on clinical trial documents including clinical trial protocols, case report forms (eCRF), investigator brochures, consent forms, and CSRs. I have worked as Lead Narrative Writer, Medical writing and was responsible for end-to-end CSR narrative writing, leading and managing team of professionals to deliver high quality narratives associated with the client’s/sponsor’s products from clinical trials for CSRs in accordance with regulatory and client’s requirement. I have worked as the Safety representative for Study Management Team of various studies/molecules for various pharma giants. Additionally, I also have authored safety sections as Parexel Safety Scientist for Periodic Benefit Risk Evaluation Reports (PBRERs), Development safety update reports (DSUR), PADERs, and Six-monthly SUSAR Reports (SSRs). I was fully involved in annual refresher trainings and mentoring of new PV recruits and PV scientists. I have also worked as a Principal Drug Safety and Risk Management Writer supporting various North American clients and sponsors.

I have done Masters in Pharmaceutics with specialization in Pharmaceutics.