
Srilakshmi Amirtheswaran
Healthcare
About 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
|
Experience
• 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
|
Education
MBBS, professional Diploma in Pharmacovigilance
Professionals in the same Healthcare sector as Srilakshmi Amirtheswaran
Professionals from different sectors near Bengaluru, Bengaluru Urban
Other users who are called Srilakshmi
Jobs near Bengaluru, Bengaluru Urban
-
We are seeking an Associate Director- Energy to join our Transmission & Distribution team in India.This is an exciting opportunity for a motivated engineer to contribute to impactful Energy projects across global offices and continue developing their technical expertise in a supp ...
Bengaluru1 month ago
-
Huron helps its clients drive growth, enhance performance and sustain leadership in the markets they serve. · We help healthcare organizations build innovation capabilities and accelerate key growth initiatives. · ...
Bangalore India - South rd Floor3 weeks ago
-
We are seeking an experienced Senior Manager with strong consulting skills and deep industry expertise in Regulatory Affairs and Pharmacovigilance to lead IT implementation projects in regulated GxP environments. · Lead regulatory strategy/ pharmacovigilance (Safety) strategy dev ...
Bengaluru3 weeks ago