Pratik Chavan
Safety and Pharmacovigilance coordinator at Syneos || Drug safety associate || GPS MAP safety scientist || Ex- TCSer
- Role
- Safety and Pv Coordinator at Syneos Health
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Pratik Chavan
As a Safety & Pharmacovigilance Coordinator at Syneos, I contribute to safeguarding…
Experience
Safety and Pv Coordinator
Aug 2025 — Present · Pune, IN
Responsibilities: Activities related to SPOR / IDMP if required.Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the PharmacovigilanceSystem Master File for post-marketing programs as appropriate.Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug levelFosters constructive and professional working relationships with all project team members, internal and external.Participates in audits as required/appropriate.Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.Monitors and routes incoming information to the appropriate project if required.Ensures current conventions are followed when entering cases into the Safety database.May perform file creation, tracking, retention, and maintenance (paper and electronic).Performs or assist with query follow up process as instructed.Assists with daily workflow reconciliation.Assists with literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding, if required.Assists with narrative writing.Assists with coding events, medical history, concomitant medications, and tests.Assists in the generation of timely, consistent, and accurate reporting of expeditedreports in accordance with applicable regulatory requirements.Validation of xEVMPD product records, including appropriate coding of indicationterms using MedDRA, if required.Manual recoding of un-recoded product and substance terms arising from ICSRs ifrequired.Identification and management of duplicate ICSRs if required.Redacts patient identifying information/ images in accordance with data protectionguidelines, ICH GCP and GVP if required.
Education
Marathwada Mitra Mandal's College of Science Pune 33
Higher Secondary School Certificate (HSC)
2017 — 2019
DY Patil International School
Secondary School Certificate (SSC)
2005 — 2017
Marathwada Mitra Mandal's College of Pharmacy, Pune 33
Bachelor of Pharmacy - BPharm
2019 — 2023
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.