Abhyangshree Mane
Safety & Pharmacovigilance Specialist II (Immediate Joiner)
Pune,MH
Summary
Result driven Pharmacovigilance expert with over 7.8 years of experience in the pharmacovigilance domain, including 4 years and 3 months at Syneos Health as a Safety & PV Specialist II and I. Extensive background in the Contract Research Organization (CRO) sector, complemented by 2.8 years as a Senior Process Associate at TCS and 11 months as a Drug Safety Associate II in Business Process Outsourcing (BPO). Proven track record of translating unique insights into actionable outcomes, consistently supporting bio-pharmaceutical clients in expediting the journey from lab to life. Therapeutic area expertise includes bio-oncology drugs, non-oncology drugs, and vaccine products, underscoring a commitment to enhancing patient safety and product efficacy while pursuing a full-time role that presents professional challenges and utilizes strong interpersonal skills, effective time management, and problem-solving capabilities. Adept at managing duplicate detection, literature triaging, and acting as a Single Point of Contact (SPOC) for high-stakes deviation projects. Also in end-to-end ICSR management, data analysis, and quality review. Advanced proficiency in managing global safety databases including ARGUS, ARISg, SAPPHIRE, EVWEB, DST and MedDRA coding. Expert in primary and secondary review of spontaneous, clinical trial, literature, and pregnancy cases, Proven track record of successfully managing multiple projects and developing innovative solutions. Immediate Joiner.
Overview
2
2
Certifications
8
8
years of professional experience
Work History
Safety & PV Specialist II
Syneos Health
10.2023 - 06.2026
- Worked as an ICSR Secondary Reviewer in the ICSR project for spontaneous cases, including serious cases (meeting all seriousness criteria), literature cases, clinical trial cases, pregnancy cases, etc.
- ICSR Primary Reviewer: Cross-checking all the structured data in E2B fields with the narrative for any inconsistencies or missing information, and marking findings for the same in the primary review document for organizations: MAH, Sponsor, NCA. Handled the primary review of cases as spontaneous (serious, including all seriousness criteria; non-serious), literature cases, clinical trial cases, and pregnancy cases.
- Performing duplicate detection: Working as a data entry user, which includes all types of cases (Spontaneous, CT, and other studies). JIRA/SIN tickets, reviewing and creating a master of identified MLM cases.
- Additional activities: SPS check, documentation, and MOM documentation for internal meetings and trainings. Support activities for newly joined associates in ICSR, by providing a basic demo of the ICSR process, query handling, and conducting quality huddles.
- Literature cases review, triage, and processing.
- Tools handled: EVWEB, DDC, Dialog Solutions Drug Safety Triager Tool (MLM).
- Mentored junior specialists, promoting skill development and operational excellence within the team.
- Developed training materials to enhance staff proficiency and productivity.
Safety and PV Specialist- I
Syneos Health
03.2022 - 09.2023
- Case processing: End-to-end data entry of ICSR (simultaneously worked in different NCAs, total NCAs covered count: 6).
- Quality check: End-to-end quality check of ICSRs.
- MedDRA coding.
- Implemented new training programs for staff, leading to higher employee retention rates, and better overall performance.
- Streamlined workflow processes, resulting in improved timelines and resource allocation.
Drug Safety Associate- II
Bioclinica, India
04.2021 - 03.2022
- Case Processor: End-to-end case processing of vaccine cases.
- Quality review: End-to-end quality check of vaccine cases.
- Tools handled: ARISg, ARGUS, Sapphire v. 10.
- Improved patient safety by accurately reviewing and processing adverse event reports.
- Assisted in the development and implementation of training materials, contributing to the ongoing education of fellow Drug Safety Associates.
Senior Process Associate
TCS, Mumbai
08.2018 - 04.2021
- Literature case processing: Ensuring accurate data entry, and timely submission to regulatory authorities. Utilized validated PV databases (e.g., ARISg) for literature case processing and reporting. Performed comprehensive literature screening and case identification in compliance with global PV regulations.
- Case processor: Data entry: End-to-end ICSR processing. Type of cases handled: interventional clinical trials, non-interventional studies/programs, spontaneous reports, MAP cases, literature cases, clinical trial cases.
- Quality Review: End-to-End QC of processed ICSR, MEDDRA coding review, causality assessment, labeling, follow-up entry check/update, and submissions to drug safety.
- SPOC: For supportive projects, deviation projects. Query handling, assist in the preparation of training documents.
- Backup Workflow Manager (WFM) activities: assignments and reassignments of cases, monitoring multiple FTEs. Transmission, tracking of exception cases, and LP cases.
- Reconciliation activities (Sponsor): CTV: CTV of CT, LP cases. Reconciliation activities of CT, LP cases.
- Handling team activity like: Leave planner, tracking serious and non-serious listings, Late case RCA and CAPA management activity.
- Tools handled: ARISg, ARGUS
- Maintained accurate documentation of processes, facilitating easy reference for internal audits and knowledge transfer.
Education
Masters - Pharmacy
Sinhgad College of Pharmacy
Pune, India01-2018
Bachelor - Pharmacy
Satara College of Pharmacy
Satara01-2016
Skills
Adverse drug reaction (ADR) detection, Documentation & Reporting
Serious adverse event (SAE) identification and escalation
ICH-GCP and regulatory compliance awareness
Expert in database: ARGUS, ARISG, SAPPHIRE, MEDDRA, Evweb, DDC, DST
MS office proficiency
Effective verbal communication, Team collaboration
Quality review
Root-cause analysis, CAPA management
Resource allocation
KEY ACHIEVEMENTS
- Processing Time Reduction: Reduced case processing time by 40% using advanced software tools and techniques.
- Submission Delay Reduction: Reduced case submission delays by 35% through workflow optimization in ICSR management.
- Processing Accuracy Boost: Increased ICSR processing accuracy by 25% through improved review checklists.
Certification
18-MAR-2022 English Score core skills
PUBLICATIONS & PRESENTATIONS
- 09-MAY-2016 Abhyangshree Mane, Formulation and Evaluation of herbal Anti-acne Face wash, World journal of Pharmacy and pharmaceutical sciences, 2016, 5(6), 2001-2007.
- 09-MAY-2016 Abhyangshree Mane, Formulation and Evaluation of Polyherbal Anti-acne Face wash gel, World Journal of Pharmaceutical research, 2016, 5(7): 1184-1190.
- 09-MAY-2016 Abhyangshree Mane, Use of Combretum indicum flower extract as a natural indicator in acid base titrations, international Journal of Institutional Pharmacy and life sciences, 2016, 6(30, 316-324.
- 01-JAN-2014 Abhyangshree Mane, Nanosuspension A Novel Carrier For Lipidic Drug Transfer, Sch. Acad. J. Pharm., 2014; 3(1): 82-88 .
- 15-OCT-2013 Abhyangshree Mane, Nanocochelates: A novel carrier for drug transfer, Journal of Scientific and Innovative Research 2013; 2 (5): 964-969.
Accomplishments
- Awarded twice with spotlight for high performance and quality (Star performer) 2019 and 2020.
- Molecule lead, Workflow management activities, mentoring and supported training document creation.
Timeline
Safety & PV Specialist II
Syneos Health
10.2023 - 06.2026
Safety and PV Specialist- I
Syneos Health
03.2022 - 09.2023
Drug Safety Associate- II
Bioclinica, India
04.2021 - 03.2022
Senior Process Associate
TCS, Mumbai
08.2018 - 04.2021
Bachelor - Pharmacy
Satara College of Pharmacy
Masters - Pharmacy
Sinhgad College of Pharmacy