Ruchira Vichare
Mohali
Summary
Patient Safety Specialist with 6+ years of progressive experience in pharmacovigilance, specialising in complex case handling and regulatory compliance. Demonstrated expertise in end-to-end ICSR processing for clinical trial and post-marketing cases, ensuring adherence to SLA/KPI targets and quality standards. Contributed for enhanced efficiency and audit readiness. Recognised for mentoring new team members and providing SME support in safety systems, MedDRA coding, and causality assessment.
Overview
2
2
Languages
10
10
years of professional experience
Work History
Patient Safety Specialist
Parexel International Service India Private Limited
04.2026 - Current
- Provided SME support for complex safety cases, including seriousness and causality assessment, and resolution of case-processing challenges.
- Perform quality review and oversight of ICSR processing, ensuring adherence to client SOPs, regulatory requirements, and quality standards.
- Support SLA/KPI achievement and timely case completion by identifying workflow issues and supporting their resolution.
- Support deviation documentation, root-cause analysis, and CAPA activities to strengthen process compliance.
- Mentor and support new team members on case processing, MedDRA coding, regulatory requirements, and safety systems.
- Support audit readiness and client/internal stakeholder coordination for the timely resolution of case-related queries.
- Contribute to process improvement and operational efficiency through the identification of recurring issues and improvement opportunities.
Patient Safety Associate II
Parexel International Service India Private Limited
04.2023 - 03.2026
- Independently managed end-to-end ICSR processing for clinical trial and post-marketing cases from triage through submission.
- Performed seriousness, causality and expectedness assessments; ensured accurate MedDRA/WHO-DD coding and narrative development.
- Managed follow-ups with sites/CROs and supported resolution of missing or conflicting safety information.
- Performed EDC-Argus reconciliation and safety data review to ensure completeness and consistency.
- Maintained SLA/KPI, quality and regulatory requirements while supporting team queries, knowledge sharing and process improvement.
Patient Safety Associate I
Parexel International Service India Private Limited
11.2019 - 03.2023
- Managed intake, triage and data entry of spontaneous, literature and clinical trial ICSRs.
- Performed seriousness and preliminary causality assessment and supported complex case processing and reporter follow-up.
- Ensured accurate documentation in accordance with client guidelines, SOPs and global pharmacovigilance requirements.
Executive - Tissue Culture Production
Mahindra HZPC Pvt. Ltd.
10.2016 - 11.2019
- Managed large-scale tissue culture plant production with focus on efficient resource utilization and cost-effective operations.
- Contributed to significant cost reduction and business benefit through production/process optimization; recognized as Best Performer for overall contribution.
Education
Master's - Biotechnology
Panjab University
Chandigarh01.2016
Bachelor's - Biotechnology
Punjab Technical University
Jalandhar01.2014
Skills
- Team Mentoring and Training
- SME support
- Operational Coordination
- SLA/KPI management
- Process Improvement
- End-to-end ICSR processing
- Clinical Trial and Post-Marketing Cases
- Case Intake and Triage
- Complex Case Handling
- Blinded and Unblinded Cases
- Follow-up management
- MedDRA
- WHO-DD
- Seriousness Assessment
- Causality Assessment
- Expectedness Assessment
- Narrative Writing
- Risk–benefit analysis
- Quality Control/Review
- Regulatory Reporting
- PV Compliance
- SOP/Work Instruction Adherence
- Audit Readiness
- Deviation Documentation
- CAPA Support
- Oracle Argus Safety
- PRIMO
- EDC-Argus Reconciliation
- Safety Data Review
Languages
English
Hindi
PROJECTS & TRAINING
- AI in Pharmacovigilance – Cuminds
- Qualified Pharmacovigilance Professional Training in Case Processing – Academy of Clinical Intelligence, Chandigarh
- 6-month dissertation: “Alaninebu2SnO as an Antibacterial Agent”
linkedin.com/in/ruchira-vichare-ba6069119
Timeline
Patient Safety Specialist
Parexel International Service India Private Limited
04.2026 - Current
Patient Safety Associate II
Parexel International Service India Private Limited
04.2023 - 03.2026
Patient Safety Associate I
Parexel International Service India Private Limited
11.2019 - 03.2023
Executive - Tissue Culture Production
Mahindra HZPC Pvt. Ltd.
10.2016 - 11.2019
Master's - Biotechnology
Panjab University
Bachelor's - Biotechnology
Punjab Technical University