Parikshit Kene

Pharmacovigilance specialist handling PV Agreements and Safety Clauses across multiple international markets. Conducted root cause analyses (RCA) and implemented CAPAs (Corrective actions and preventive action). Specialist in ICSR (Individual case safety report), case reconciliation (Vaccine) with healthcare tools. Committed to maintaining confidentiality and ensuring compliance with healthcare regulations. Can join right away.

PV Agreement Specialist Lead at TATA Consultancy Services (TCS) (2019-04 – 2025-09)

Led PV Agreements and Safety Clauses activities, managed PVASC team, oversaw end-to-end relevant activities including drafting, reviewing, amending and maintaining PVA/SC agreements, compliance checks, periodic reviews, and preparation of monthly bulletins.

• Primary point of contact and responsible for external service provider for PVASC related activities in relevant countries
• Led the PVASC team, overseeing the end-to-end relevant activities
• Drafting, reviewing, amending and maintain PVA/SC agreements
• Compliance Checks for PVA
• Periodic Review
• Preparation and presentation of monthly Bulletin with client and team
• Managed daily allocations, status tracking, and timely billing, aligned with process compliance
• Mentored new and existing staff for upcoming Ad Hoc activities, audit preparation and independent Project execution
• Host-focused meetings with reviewers, trainers, and associates to fulfill client expectations
• Ensured strict adherence to data security protocols and organizational confidentiality guidelines
• Evaluate CAPA effectiveness, and revise strategies as needed
• Documentation, Archival and preparation of MOM of daily, weekly connects, meeting schedule with client, follow-up tracking in one note
• Review adverse even reports (ICSRs) received from- Spontaneous (E2b) and/or solicited and/or Clinical trial and/or health professionals, sales representative, consumers, licensing partners and vaccine information centers in currently defined case handling procedure with specified productivity and quality targets
• Co-ordinate and conduct knowledge sharing sessions and mentor junior staff in Pharmacovigilance methodology and in processing
• Database Used: Argus (Analytical Reports Gathering and updating System), Veeva Vault, Medidata Rave EDC and Inform
• To perform Reconciliation activities including Step 1 Reconciliation (In stream/Final) and Step 2 Reconciliation (end of study un-blinding)
• Reconciliation activity Vaccine CT, SAE (Paper), EDC (Electronic data captured), FSO (Full service outsource) and VEEVA database cases
• Responsible for Mailbox monitoring and management which includes but not limited to the following: VCSP external mailbox for book in activities and PVASCGSP mailbox for PVASC stakeholder requests

ADSL (Acting Drug Safety Lead) at Cognizant Technology Solutions Pvt. Ltd. (2013-07 – 2019-03)

Managed operation and people to meet developmental KPIs. Performed Late Case Analysis (LCA) and RCA, filling CAPA actions for any missed case. Identified literature and litigation documents, managed training of new recruits for Drug Safety and Case Processing roles.

• Motivate and develop the team members to meet developmental KPIs
• Performing Late Case Analysis (LCA) and RCA and filling a CAPA action for any missed case, late case with respect to all workflow and if quality drops
• Identifying literature and litigation documents, Downloading and maintaining their records and managing cases from LRD to till time lme
• Managed training of new recruits: Trained resources for Drug Safety and Case Processing for handling the job role of Drug Safety Specialist
• Keep training, productivity, and quality records inspection-ready, support audit participation and readiness
• Participate in client calls and updates, resolve queries and escalations efficiently, and ensure all issues are addressed per escalation protocols

Regulatory Officer at LifeSan clinical research, division of Centaur Pharmaceuticals Pvt. Ltd (2011-05 – 2013-06)

M.Sc in Clinical research and Regulatory affairs (CRRA) – Sikkim Manipal University

T.Y.Bsc in Microbiology – Mumbai University

Diploma in Biotechnology – Mumbai University

H.S.C – Maharashtra board

S.S.C – Maharashtra board