Headline

Senior Drug safety associate| Ex-Fortrean | Ex-TCSer.

About

Experienced Safety Administrator with a demonstrated history of working in the information technology and services industry. Skilled in GMP, Regulatory Affairs, Patient Safety, Pharmacy, and Standard Operating Procedure (SOP). Strong healthcare services professional with a Bachelor of Pharmacy - BPharm focused in Pharmacy from Nagpur University Academic foundations in Pharmacy (BPharm) and Human Resources (MBA) complement a professional background in safety science, including prior roles at Covance and Tata Consultancy Services. Motivated by a commitment to improving patient safety, the focus remains on streamlining processes and fostering collaboration across multidisciplinary teams.

Location

Navi Mumbai

Work experience

Senior drug safety associate at EVERSANA, Nov 2023 - Present · 2 yrs 9 mos, Pune, Maharashtra, India

Drug Safety Associate at EVERSANA, Nov 2023 - Present · 2 yrs 9 mos, •Safety database Used: Argus. •Working with different clients among which primarily working on clinical trial cases (oncology study), In which my key responsibility is to fulfill client's requirements starting with Case book In, Triage notification, Case processing, Quality checks, and case submission along with raising queries to the PI's or clinical trial sites. Also doing monthly SAE reconciliation. Also, working on spontaneous cases which includes license partner cases, literature cases, patient support programs and solicited cases (Case processing, QC and Queries, and submission to clients). Currently i am SME for regulatory downloads i.e, MHRA, EMA, USFDA, TGA, FAERS, HEALTH CANADA.

safety Science Co-ordinator 1 at Covance, Mar 2021 - Nov 2023 · 2 yrs 9 mos, Pune, Maharashtra, India

Patient Safety Administrator at Tata Consultancy Services, Jul 2019 - Mar 2021 · 1 yr 9 mos, Nagpur, Maharashtra, India

Education

Master of Business Administration - MBA, Human Resources Management and Services, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur

Bachelor of Pharmacy - BPharm, Pharmacy, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur