Titiksha Chavan
Pharmacovigilance Associate
Thane,maharashtra
Summary
Experienced pharmacovigilance professional with 4+ years of expertise in SDEA/PVA management, regulatory compliance (GVP, EMA, MHRA), and PSMF oversight. Skilled in safety case processing using Oracle Argus and conducting partner data management in Veeva BDLM. Demonstrated success in MHRA inspection readiness, effective stakeholder communication, and thorough risk assessment. Proficient in SOP development, managing safety mailboxes, and fostering cross-functional collaboration within global PV operations.
Overview
4
4
years of professional experience
Work History
Pharmacovigilance Consultant (Executive)
Crescent Pharma Ltd.
11.2023 - Current
- MHRA GVP Inspection: Actively contributed to a successful MHRA pharmacovigilance inspection by ensuring end-to-end compliance with Good Pharmacovigilance Practice (GVP) guidelines and regulatory requirements. Coordinated cross-functional readiness activities, resulting in zero critical findings.
- SDEA Management: Drafted, negotiated, and executed Safety Data Exchange Agreements (SDEAs) with international pharmaceutical partners. Oversaw the full lifecycle—from initiation to renewal or termination—ensuring alignment with global regulatory obligations and company standards.
- Stakeholder Communication: Acted as a liaison between internal departments and external partners to resolve pharmacovigilance issues, facilitating timely and compliant information exchange.
- Risk Management & Auditing: Conducted pharmacovigilance risk assessments and vendor audits to evaluate partner compliance with applicable regulations. Implemented corrective actions where necessary to mitigate compliance risks.
- PSMF Oversight: Maintained and regularly updated the Pharmacovigilance System Master File (PSMF) in accordance with EU and UK regulatory frameworks. Ensured documentation accuracy for inspections and audits.
- Safety Mailbox Management: Oversaw the intake, triage, follow-up, and reconciliation of individual case safety reports (ICSRs), safety-related queries, and product quality complaints via the safety mailbox.
- Case Processing: Utilized the Oracle Argus Safety Database to manage pharmacovigilance case workflows, including data entry, case evaluation, narrative writing, and timely follow-up in compliance with global health authority timelines (e.g., EMA, MHRA, FDA).
- SOP Development & Documentation: Authored and maintained standard operating procedures (SOPs), work instructions, and training materials. Ensured documentation was audit-ready and in compliance with internal QA requirements.
- Training & Compliance: Designed and delivered pharmacovigilance training sessions for internal teams and third-party vendors to ensure consistent understanding and application of PV regulations and internal SOPs.
Senior Process associate : Pharmacovigilance
Tata Consultancy Services
08.2021 - 10.2023
- PVA Data Management: Managed and accurately entered Pharmacovigilance Agreement (PVA) metadata into the Veeva Business Development Lifecycle Management (BDLM) system, ensuring timely updates and data integrity across partner profiles.
- Data Quality & Auditing: Conducted quarterly random audits of BDLM entries, cross-referencing with source documentation to validate accuracy and consistency of metadata fields and regulatory information.
- Agreement Lifecycle Oversight: Administered the full lifecycle of Safety Data Exchange Agreements (SDEAs), including drafting, reviewing, routing for signature, and ensuring system updates were completed in accordance with procedural timelines.
- Compliance Monitoring: Led quarterly compliance reviews of active SDEAs, ensuring all agreements met internal SOPs and evolving global regulatory requirements (e.g., EMA, MHRA, FDA).
- Partner Communication: Efficiently managed the pharmacovigilance partner mailbox, coordinating safety data reconciliation and resolving contract-related queries to ensure seamless collaboration with external stakeholders.
- Quality Assurance: Performed detailed quality checks of PV agreements, amendments, and safety data exchange documentation to ensure accuracy, compliance, and audit readiness.
- Vendor Data Management: Maintained and updated vendor databases to reflect the most current and accurate partner information, supporting inspection-readiness and global operational transparency.
Education
Master of Science - Microbiology
Modern College
Pune 04.2001 -
Skills
Knowledge of GVP standards
Pharmacovigilance System Master File (PSMF)
Safety data management agreements
Collaborative teamwork
Proficient in MS Office
Proficient in Oracle Argus Safety
Veeva business development lifecycle management
ICSR management
Safe mailbox management
Attention to detail
Timeline
Pharmacovigilance Consultant (Executive)
Crescent Pharma Ltd.
11.2023 - Current
Senior Process associate : Pharmacovigilance
Tata Consultancy Services
08.2021 - 10.2023
Master of Science - Microbiology
Modern College
04.2001 -