Snehal Ambadkar
Team Leader
Pune
Summary
Experienced Pharmacovigilance (PV) Team Leader with 11 years in the field, dedicated to driving success in drug safety and regulatory compliance. Proven track record in managing teams for efficient PV operations, overseeing adverse event reporting, signal detection, risk management, and regulatory submissions. Skilled in implementing PV processes and quality assurance measures to ensure global regulatory compliance. Committed to mentoring team members for operational excellence and achieving business objectives in pharmacovigilance.
Overview
11
11
years of professional experience
1
1
Certification
3
3
Languages
Work History
Drug Safety Operation Lead
Qinecsa
10.2021 - Current
- Functioned as the designated backup for the manager to ensure continuity of operations
- Led and oversaw end-to-end ICSR case processing activities, ensuring compliance with global regulatory requirements and operational efficiency.
- Managed workflow optimization and resource allocation to meet SLAs, TATs, KPIs, SOPs, and client-specific deliverables.
- Drove quality initiatives by identifying trends, performing root cause analysis (RCA), and implementing CAPAs to mitigate risks and enhance performance.
- Coordinated team leave planning to ensure consistent case coverage and avoid workflow disruptions.
- Facilitated team development through mentoring, ongoing coaching, and delivery of training sessions for new hires.
- Ensured audit and inspection readiness by maintaining accurate records, reinforcing compliance with global PV standards, and conducting regular internal process reviews.
- Maintained essential project documentation, including RAID logs, meeting minutes, and project plans, while supporting Business Continuity Planning (BCP) and system readiness through User Acceptance Testing (UAT).
- Led process improvement initiatives to streamline workflows, enhance case quality, and support continuous operational excellence.
- Conducted quarterly and annual performance reviews using stack ranking to evaluate team contributions and support professional growth.
Lead Safety Science Specialist
Labcorp (formerly Covance)
01.2017 - 08.2021
- Acted as the team’s primary point of contact in the absence of the Team Leader, demonstrating leadership and accountability in operational decisions
- Supervised day-to-day ICSR processing activities—including triage, data entry, and submissions—ensuring adherence to SLA, SOPs and regulatory requirements
- Performed quality control (QC) checks to identify recurring issues and implement internal corrective and preventive actions (CAPAs)
- Conducted first-level review and approval of complex and escalated cases, ensuring accuracy, consistency, and timely submissions
- Managed project-related communications, including client mailbox monitoring, status updates, and participation in stakeholder meetings
- Mentored and supported team members, including onboarding and training of new hires to ensure smooth integration and performance readiness
- Assisted with CAPA closure, audit readiness, and inspection preparation by maintaining thorough documentation and compliance reports
- Contributed to continuous process improvement through SOP revisions, tracker maintenance, and documentation optimization
Safety Data Analyst
Covance (formerly Sciformix)
01.2016 - 12.2016
- Performed peer reviews of ICSR safety reports to ensure accuracy, consistency, and regulatory compliance
- Supported clinical trial configurations within the Argus Safety database and led User Acceptance Testing (UAT) to validate system enhancements
- Managed project mailbox communication, ensuring timely triage, response, and documentation of safety-related correspondence
- Mentored and trained new team members, providing ongoing guidance and conducting structured performance feedback sessions
- Led initiatives to improve team quality and productivity by identifying process gaps and supporting implementation of corrective actions
- Maintained and updated team-level trackers for productivity, quality review, and LMS training compliance to support audit readiness
- Monitored and coordinated resolution of IT-related issues affecting safety systems, ensuring minimal disruption to workflows
Junior Safety Data Analyst
Sciformix
01.2015 - 12.2015
- Managed safety report book-in, data entry, follow-ups, and review to ensure accurate and timely case processing
- Conducted medical literature assessments to identify valid ICSR
- Developed and maintained literature search string aligned with product updates to enhance signal detection efforts
- Assisted in data reconciliation activities between safety databases and external sources to ensure data integrity
- Collaborated with cross-functional teams to facilitate smooth case processing and improve operational efficiency
Trainee Safety Data Analyst
Sciformix
04.2014 - 12.2014
- Experienced in using Argus Safety database for ICSR case processing and narrative writing
- Generated follow-up questionnaires and contacted healthcare professionals to gather additional case information
- Ensured ICSR processing compliance with SOPs, regulatory requirements, and service level agreements (SLAs)
Education
Master of Pharmacy - Pharmaceutical Chemistry
Amravati University
Bachelor of Pharmacy -
Amravati University
Skills
- ICSR processing (triage to submission)
- Pharmacovigilance regulatory knowledge
- Experience with MedDRA and WHO-DD coding
- Case handling: spontaneous, solicited, literature, clinical trial, post-marketing
Skilled in utilising Argus and ARISgg for safety reporting
- Resource allocation and performance monitoring
PV staff training & on-boarding
- Compliance and audit preparation
- Deviation, CAPA, and process improvement
- Case processing metrics & KPI monitoring
Certification
Registered Pharmacist, Maharashtra State Pharmacy Council, India
Accomplishments
- Boosted case processing efficiency by 20% through workflow and resource optimization.
- Reduced ICSR quality errors by 30% via CAPA implementation, spot check, one to one connects, address concerns and improved peer review.
- Trained and onboarded 25+ team members, cutting ramp-up time by 40%.
- Supported audit readiness; contributed to inspections with zero critical findings.
- Consistently delivered >98% quality and >99% on-time submission performance.
Timeline
Drug Safety Operation Lead
Qinecsa
10.2021 - Current
Lead Safety Science Specialist
Labcorp (formerly Covance)
01.2017 - 08.2021
Safety Data Analyst
Covance (formerly Sciformix)
01.2016 - 12.2016
Junior Safety Data Analyst
Sciformix
01.2015 - 12.2015
Trainee Safety Data Analyst
Sciformix
04.2014 - 12.2014
Master of Pharmacy - Pharmaceutical Chemistry
Amravati University
Bachelor of Pharmacy -
Amravati University
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