Chetan C.
Principal Safety & Pharmacovigilance @Syneos Health
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WORK HISTORY
Principal Safety & Pharmacovigilance @Syneos Health
IN
Deputed at Sanofi India as a Pharmacovigilance Manager - Southeast Asia & India safety operations.Core Safety Operations:Assist Country Safety Head in ADR/AE collection and reporting. Oversee vendor QC and compliance. Manage Periodic Safety Reports per SOPs and local regulations. Support Patient Program approvals and vendor PV onboarding. Ensure reconciliations & conduct refresher trainings. Plan, track, and monitor MPT & ATT activitiesBusiness Development & Integration:Due diligence & integration for in-licensing, co-marketing, and acquisitions. Manage cross-functional stakeholder relationships (BPQA, BD, Legal, Supply Chain). Support vendor selection, onboarding and transitions in line with PV outsourcing strategies. Assist in reviewing and approving vendor invoices where requiredVendor Oversight & Governance:Oversee the implementation of PV outsourcing activities in alignment with governance procedures, relationship manuals, & escalation mechanisms. Ensure vendors meet agreed KPIs/SLAs & comply with all contractual and regulatory requirements. Monitor vendor efficiency & drive process and productivity improvements in collaboration with vendor managers and SMEs. Contribute to vendor governance/relationship meetings in accordance with oversight documentation. SDEA/PVA management:Identify agreements requiring PVAs and ensure compliance with safety standards. Implement and revise Safety Data Exchange Agreements (SDEAs). Embed PV requirements in contracts and service agreements.LPSF Management:Maintain Local PV System File (LPSF) aligned with global/local requirementsTraining & Compliance:Conduct PV awareness, induction & refresher trainings. Coordinate Health Authority queries, safety alerts & product recalls. Liaise with LSO, GSO, & GPE for regulatory queries and actions. Support safety reporting, BPPQRA activities, & MyAlliance updatesQuality Assurance & Support:Assist in PV audits, inspections, & readiness activities. Act as backup CSM & PVOI/LPPV.
EDUCATION
Savitribai Phule Pune University
M Pharma , Pharmaceutical Sciences
Rutgers University
Procurement and strategic sourcing
Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm, Pharmacy
ABOUT CHETAN C.
With over a decade of specialized experience in pharmacovigilance and drug safety, I bring comprehensive expertise in leadership, operational excellence, and regulatory compliance. Currently serving as Principal Safety & Pharmacovigilance at Syneos Health, deputed at Sanofi India as Pharmacovigilance Manager for Southeast Asia & India MCO safety operations, I oversee ADR/AE management, vendor compliance, local periodic safety reports, PVA & SDEA, LPSF management, and patient program approvals. As backup LPPV for India, LSO, and country safety head, I ensure adherence to regulatory requirements and the highest quality standards.As Drug Safety Operations Lead at Qinecsa Solutions (20••••24), I managed large-scale operations including affiliate ICSR follow-up, medical information call center, literature screening, and case processing while leading teams of up to 56 professionals across multiple projects, overseeing hiring, training, and performance management.My foundation was built during 8+ years at Tata Consultancy Services, progressing from Senior Process Associate to Assistant Manager. I led safety aggregate reporting initiatives (PAER/PADER, PSUR, LSSR, LLR, SUSAR), managed regulatory submissions, conducted RCA and CAPA implementations, and served as SME liaison between sponsors and operational teams. I specialized in ICSR processing, quality review, medical coding (MedDRA/WHODD), narrative writing, and causality assessments.My expertise spans regulatory submissions, safety aggregate reporting, pharmacovigilance quality systems, vendor management, team leadership, and compliance oversight. I am committed to delivering robust, compliant safety outcomes that prioritize patient well-being while driving operational efficiency across the global pharmaceutical landscape.
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