SKSelva Kumar
@selvakumar
Subject Matter Expert in drug safety and pharmacovigilance
IndiaWhat I'm looking for
Highly experienced Subject Matter Expert in drug safety and pharmacovigilance with close to 18 years of extensive experience in handling adverse event reports and managing pharmacovigilance deals. Proven track record of delivering high-quality results and leading teams to achieve exceptional performance.
Skilled in ICSR, PADER, PBRER, RMP, client engagement, delivery management, P&L management, new business planning, RFP, RCA CAPA for audits and inspections, forecasting, hiring, and training. Passionate teacher with experience in training over 500 members in drug safety and pharmacovigilance.
Currently working as Deputy General Manager-PV at Apotex Pharma, leading a team of 100 members and responsible for ICSR submissions, aggregate reports, and signal management.
Experience
Work history, roles, and key accomplishments
Deputy General Manager-PV
Apotex Pharma Research Private Ltd
Mar 2023 - Present (2 years 2 months)
Currently leading a 100-member team in pharmacovigilance, managing ICSR submissions and aggregate reports like PBRER, PADER, and RMP. Responsible for ensuring timely processing of adverse event reports and maintaining regulatory compliance.
Delivery Manager-PV
Cognizant Technology Solutions Private Ltd
Nov 2019 - Feb 2023 (3 years 3 months)
Managed a team of 300 members in pharmacovigilance, ensuring compliance with service delivery management for adverse event reports. Oversaw financial planning and quality assurance processes.
Operations Manager-PV
Accenture Pharma Services Private Ltd
Aug 2007 - May 2016 (8 years 9 months)
Led a team in processing adverse event reports and ensuring compliance with regulatory standards. Managed client communications and team performance evaluations.
Assistant Dental Surgeon
Private Dental Clinic
Oct 2006 - Feb 2007 (4 months)
Performed minor surgeries and general dental treatments, assisting in specialized treatments and managing emergency patient care.
Education
Degrees, certifications, and relevant coursework
Selva hasn't added their education
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Availability
Location
IndiaAuthorized to work in
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