Srilakshmi Amirtheswaran

•        Technically resourceful, detail oriented senior pharmacovigilance Physician/QPPV with a decade of specialized hands-on experience in end-to-end delivery of PV projects 

•        Highly skilled in various aspects of PV including medical review of ICSRs, aggregate reports (PSURs/PBRERs), signal detection and risk management, continuous benefit risk monitoring of medicinal products (pre- and postmarketing) and PSMF maintenance 

•        Proven ability to manage and lead PV teams with a clear vision and strategic direction

•        Outstanding success in independently handling branded and generic portfolios including biologics/biosimilars and vaccines for pharma companies like Novartis, Sandoz, Amgen, Pfizer, AstraZeneca, Viatris, Lotus and Alvogen wherein I was recognized for my customer focused approach and ability to anticipate the needs of the client and deliver suitable solutions.

•        In-depth expertise in monitoring and analyzing safety data from clinical trials, protocol review, and sponsor oversight

of clinical trials

•        Subject matter expert for ICSR and risk management activities and design, development, and maintenance of PV safety Databases

•        Well versed with pharmacovigilance terminology, medical and therapeutic terminology along with proficiency of safety database (Argus, PVEdge,PVNet and ArisG)

•        Solid foundation of medical knowledge gained through clinical practice experience of about 6 years in critical care, surgical and medical oncology, endocrinology, cardiovascular disease, obesity, and metabolic syndrome

•        Technically resourceful, detail oriented senior pharmacovigilance Physician/QPPV with a decade of specialized hands-on experience in end-to-end delivery of PV projects 

•        Highly skilled in various aspects of PV including medical review of ICSRs, aggregate reports (PSURs/PBRERs), signal detection and risk management, continuous benefit risk monitoring of medicinal products (pre- and postmarketing) and PSMF maintenance 

•        Proven ability to manage and lead PV teams with a clear vision and strategic direction

•        Outstanding success in independently handling branded and generic portfolios including biologics/biosimilars and vaccines for pharma companies like Novartis, Sandoz, Amgen, Pfizer, AstraZeneca, Viatris, Lotus and Alvogen wherein I was recognized for my customer focused approach and ability to anticipate the needs of the client and deliver suitable solutions.

•        In-depth expertise in monitoring and analyzing safety data from clinical trials, protocol review, and sponsor oversight

of clinical trials

•        Subject matter expert for ICSR and risk management activities and design, development, and maintenance of PV safety Databases

•        Well versed with pharmacovigilance terminology, medical and therapeutic terminology along with proficiency of safety database (Argus, PVEdge,PVNet and ArisG)

•        Solid foundation of medical knowledge gained through clinical practice experience of about 6 years in critical care, surgical and medical oncology, endocrinology, cardiovascular disease, obesity, and metabolic syndrome