About
Results-driven Pharmacovigilance Operations Manager with 12 years of extensive experience in drug safety processes and more than 5 years in team leadership. Adept at managing Individual Case Safety Reports (ICSRs), ensuring stringent regulatory compliance, and driving continuous process improvements.
Experience4
Associate Manager
Oct 2021 — PresentFortrea INC · Pune, Maharashtra
Directed a high-performing team of 25 associates, overseeing daily pharmacovigilance operations, capacity planning, and performance management. Spearheaded daily queue management and streamlined workflows to process approximately 35,000 ICSRs monthly while maintaining compliance. Served as the primary point of contact for clients and managed the Global Adverse Event mailbox.
- Achieved 100% SLA adherence in service delivery
- Reduced late reporting incidents by 25% over the last 12 months
- Achieved and sustained 100% training compliance across all direct reports
Team Leader
Oct 2020 — Sep 2021Covance · Pune, Maharashtra
Played a key role in establishing the Inbound Receipt and Triage process for a multinational client. Managed an intake team of 10 associates and monitored workflows to ensure adherence to SOPs. Coordinated with the internal Quality team during audits and prepared weekly metrics to monitor performance.
- Contributed to successful project implementation and operational readiness
- Ensured audit readiness and compliance with quality standards
Sr. Safety Data Analyst/Safety Data Analyst
Jan 2014 — Sep 2020Sciformix Pvt. Ltd. · Pune, Maharashtra
Executed booking, triage, and event coding for Individual Case Safety Reports (ICSRs). Mentored new hires and resolved complex processing queries.
Clinical Record Processor
May 2013 — Dec 2013Syntel Pvt. Ltd. · Pune, Maharashtra
Processed clinical records within stipulated timelines and maintained quality.
Education1
Bachelor of Pharmacy
2006 — 2009North Maharashtra University