Ashish Pachore
Pharmacovigilance Agreements/SDEAs/Compliance Monitoring/PSMF Review/ICSR/Submissions
Mumbai,MH
Summary
Experienced Pharmacovigilance professional with nearly 8 years in the life sciences industry, specializing in Pharmacovigilance Agreements (PVAs), SDEAs, and Regulatory Submissions. Currently serving as a Business Process Lead at TCS within the GPVAM team, overseeing the complete PVA lifecycle, compliance metrics, and partner engagement. Proficient in managing both global and local PVAs, executing revisions, coordinating internal and external reviews, and leading process improvement initiatives. Previous roles at IQVIA and Cognizant included ICSR processing, E2B/CIOMS submissions, and ensuring regulatory compliance using Argus and Jasper databases. Strong in cross-functional collaboration, stakeholder communication, and aligning with global pharmacovigilance regulations including ICH and GVP guidelines.
Overview
8
8
years of professional experience
Work History
Business Process Lead
Tata Consultancy Services
Mumbai
05.2024 - Current
- Managing the end-to-end lifecycle of PVAs and SDEAs, including drafting, review coordination, partner negotiations, finalization, execution, archival, and ongoing compliance tracking.
- Collaborating with global cross-functional teams such as Pharmacovigilance, Regulatory Affairs, Quality Assurance, Legal, and Alliance Management to ensure timely and compliant agreement execution.
- Leading kick-off meetings for new agreements or revisions, aligning stakeholders on timelines, responsibilities, and deliverables.
- Facilitating negotiation calls and comment resolution meetings with partners and internal teams; documenting and tracking outcomes via structured Minutes of Meetings (MoMs).
- Maintaining comprehensive PVA trackers, providing real-time visibility into agreement status, revision cycles, renewal timelines, and compliance obligations.
- Overseeing Pharmacovigilance Agreement Compliance (PVAC) activities, including tracking: ICSR exchange compliance (timelines, completeness, partner acknowledgments), Aggregate report and RMP submission compliance, Additional safety commitments as per PVA clauses.
- Preparing and presenting compliance summary reports and metric slides to partners in line with contractual requirements.
- Ensuring adherence to global regulatory frameworks and internal SOPs related to safety data exchange and PVA execution.
- Creating and maintaining Note-To-File (NTF) documentation for interim compliance issues and maintaining audit-ready logs.
- Reviewing Pharmacovigilance System Master File (PSMF) components: Annex B2 of EU and UK PSMFs, Core PSMF sections for alignment with regulatory and internal expectations.
- Coordinating ICSR vendor oversight, including review of vendor compliance metrics, addressing quality issues, and supporting performance management discussions.
- Supporting audits and health authority inspections by ensuring the availability and accuracy of all PVA-related documentation and compliance evidence.
- Managing escalations, stakeholder queries, and monthly/quarterly reporting related to PV agreements.
- Contributing to process improvement initiatives, tool development, SOP enhancements, and cross-functional training to optimize operational efficiency.
Operations Specialist I
IQVIA RDS IND PVT LTD
Thane, Mumbai
05.2021 - 04.2024
- Drafted, reviewed, and executed Safety Data Exchange Agreements (SDEAs) for multiple regions including USA, India, Canada, and ROW.
- Ensured timely and compliant exchange of safety data with alliance partners as per SDEA obligations.
- Led monthly reconciliation of safety data and monitored SDEA compliance metrics, ensuring adherence to timelines.
- Maintained and updated SDEA Overview Lists, Working Trackers, and managed SDEA mailbox QC activities.
- Oversaw tracking and follow-up for executed, ongoing, and upcoming SDEAs, including those older than 3 years.
- Prepared and presented weekly compliance dashboards covering case exchange status, reconciliations, and audit timelines.
- Sent and tracked weekly execution reminders to ensure timely finalization of agreements.
- Delivered SDEA training sessions for internal teams and external vendors.
- Coordinated with Lupin subsidiaries for updates on new, revised, and terminated SDEAs and maintained overview documentation accordingly.
- Investigated late submissions to Health Authorities and alliance partners, supporting CAPA planning and implementation.
- Performed ICSR submissions via E2B gateway, CIOMS, and email/manual methods as per regulatory intelligence (RID) and SMPs.
- Assessed reportability using CRESS criteria and submitted cases to health authorities within compliance timelines.
- Managed submission workflows through Argus Safety, Jasper Reports, and Spotfire dashboards.
- Investigated and resolved submission failures, tracked late cases, documented LCCs, and supported CAPA implementation.
- Handled Regulatory Reporting Mailbox, prepared submission trackers and cover letters, and acted as backup lead for case allocation and issue resolution.
- Mentored new team members in regulatory submission processes and reconciliation activities.
Junior Data Analyst
Cognizant Technology Solutions
Airoli, Navi Mumbai
06.2018 - 05.2021
- Handled end-to-end processing of oncological ICSRs (Spontaneous, Non-Interventional Studies, Programs, HA, and License Partner reports) in Argus Safety 7 & 8, maintaining 98% average quality.
- Performed case intake, triage, duplicate check, book-in, and registration in accordance with company SOPs.
- Ensured accurate, consistent, and complete data entry of AE reports, maintaining scientific rigor and high-quality standards.
- Coded medical history, drugs, events, indications, and lab tests using MedDRA, WHO-DD, and internal dictionaries.
- Drafted clear and concise narratives summarizing clinical course and essential case information.
- Identified and followed up on missing critical data; created and tracked follow-up requests in collaboration with safety physicians.
- Performed nullification/deletion of invalid cases per SMP/SOP requirements.
- Acted as product-specific POC for Kymriah and processed key oncology drugs like Tasigna, Glivec, Jakavi, Sandostatin, etc.
- Collaborated with Country Safety Departments, Clinical Safety Scientists, and PV Leaders to ensure data integrity.
- Supported reconciliation activities, audit readiness, and acted as backup lead.
- Mentored new team members, helped them clear QC, and provided ongoing guidance as an official mentor.
Clinical Data Analyst
Inventurus Knowledge Solutions
Mumbai
07.2017 - 05.2018
- Accurately entered and segregated patient information into Electronic Health Record (EHR) systems, ensuring clarity between clinical and non-clinical data.
- Performed data validation and quality assurance checks to maintain completeness, accuracy, and consistency of patient records.
- Analysed clinical data sets to identify trends, gaps, and actionable insights to support clinical decisions and operational efficiency.
- Collaborated with clinicians, coders, and administrative teams to improve documentation quality and streamline data workflows.
- Maintained confidentiality and compliance with regulatory standards including HIPAA while handling sensitive patient data.
- Contributed to internal initiatives for workflow optimization, process standardization, and compliance alignment.
- Assisted with documentation and reporting for quality metrics, productivity dashboards, and performance tracking.
- Used internal tools and systems to ensure timely task completion within quality and performance benchmarks.
Education
Bachelor's of Pharmacy - undefined
Appasaheb Birnale Collage of Pharmacy
05.2017
HSC - undefined
Jaysingpur Collage
05.2013
SSC - undefined
Balawantroa Zele Highschool
05.2011
Skills
- Microsoft Office Word
- Time Management
- Ability to Work Under Pressure
- Analytical Thinking
- Microsoft Excel
- Microsoft Office
- Fast Learner
- Critical thinking and problem solving
- Highly organized and efficient
- Microsoft PowerPoint
- Ability to Multitask
- Effective Time Management
- Communication and Presentation
Languages
English
Marathi
Hindi
Personal Information
- Title: Business Process Lead (Pharmacovigilance Agreement & SDEA Specialist)
- Date of Birth: 30 July 1995
- Gender: Male
- Nationality: Indian
- Marital Status: Single
Awards
- 2024-12-27, Special Initiative Award, In appreciation of your outstanding contribution to the organisation, you are awarded the: Special Initiative Award. You are an inspiring role model to your colleagues. Thank you for your dedication and commitment.
- 2023-06-20, Spotlight, Ashish proactively volunteered for additional activities. He has shown excellent collaboration with different stakeholders on review of daily destinations reports and performed submissions. He took the responsibility for the nullification process along with multiple daily destinations reports review during ad-hoc absences of team members.
- 2022-12-16, Ovation, Ashish proactively volunteered for additional activities. He has shown excellent collaboration with different stakeholders on review of daily destinations reports and performed submissions. He took the responsibility for the nullification process along with multiple daily destinations reports review during ad-hoc absences of team members.
- 2018-09-30, Ace of Rookies, Awarded for best productivity and quality in mentoring phase in 2018.
Hobbies and Interests
- Reading books to explore knowledge and new things
- Riding bikes to explore new places, nature etc
Disclaimer
2025-06-15, I, Ashish Pachore, hereby declare that the information contained herein is true and correct to the best of my knowledge and belief.
Timeline
Business Process Lead
Tata Consultancy Services
05.2024 - Current
Operations Specialist I
IQVIA RDS IND PVT LTD
05.2021 - 04.2024
Junior Data Analyst
Cognizant Technology Solutions
06.2018 - 05.2021
Clinical Data Analyst
Inventurus Knowledge Solutions
07.2017 - 05.2018
Bachelor's of Pharmacy - undefined
Appasaheb Birnale Collage of Pharmacy
HSC - undefined
Jaysingpur Collage
SSC - undefined
Balawantroa Zele Highschool
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