Safety & Pharmacovigilance (PV) Coordinator – Hyderabad, India (Office-Based)
Location: Hyderabad, Telangana, India
Job Type: Full-Time
Experience Required: 1+ Years in Pharmacovigilance / Drug Safety
Job ID: 25105305
Category: Pharmacovigilance / Clinical Research
Work Model: Onsite
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, dedicated to accelerating customer success. By translating clinical, medical affairs, and commercial insights into actionable outcomes, we help our clients navigate complex market challenges.
Our Clinical Development model places the patient and customer at the center of everything we do. We continuously simplify and streamline processes to enhance operational efficiency, foster collaboration, and drive innovation across the pharmaceutical and biotechnology sectors.
At Syneos Health, you’ll collaborate with cross-functional teams, contribute to cutting-edge solutions, and directly impact the delivery of life-changing therapies. With over 29,000 employees across 110 countries, we are committed to creating a workplace where diversity, inclusion, and professional growth thrive.
The Safety & PV Coordinator will be responsible for ensuring accurate and compliant management of Individual Case Safety Reports (ICSRs), supporting post-marketing and clinical trial safety activities. This role involves detailed pharmacovigilance operations, data entry, coding, and reporting, contributing to the safe use of pharmaceutical products and regulatory compliance.
This position is office-based in Hyderabad and requires 1+ years of relevant experience in pharmacovigilance operations.
Enter, track, and manage ICSRs in PVG quality and tracking systems.
Evaluate and triage ICSR data for completeness, accuracy, and regulatory reportability.
Perform medical coding, including adverse events, medical history, concomitant medications, and lab tests using MedDRA standards.
Prepare and compile narrative summaries; query and follow up on incomplete or inconsistent data.
Validate and submit xEVMPD product records, including coding indications and substances.
Identify and manage duplicate ICSRs; maintain safety tracking for assigned activities.
Conduct literature screening and review for drug safety; maintain drug dictionaries.
Ensure all safety-related documents are accurately submitted to Trial Master Files (TMF) and Pharmacovigilance System Master Files.
Maintain compliance with SOPs, Work Instructions, ICH GCP, GVP, and relevant global drug safety regulations.
Support audits and quality review activities as required.
Foster constructive, professional relationships with internal teams, clients, and external stakeholders.
Education: Bachelor’s or Master’s in Pharmacy (B.Pharm / M.Pharm).
Experience: Minimum 1 year in pharmacovigilance operations, including post-marketing surveillance (PMS) and spontaneous case reporting.
Experience with safety databases such as LSMV or Argus.
Strong knowledge of clinical trial processes (Phases II-IV) and post-marketing safety requirements.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email (Outlook), SharePoint, and internet research.
Strong understanding of GCP, ICH guidelines, GVP, and global pharmacovigilance regulations.
Excellent attention to detail, organizational skills, and ability to manage multiple tasks with deadlines.
Strong written and verbal communication skills; ability to work independently and in a team environment.
Collaborate with industry-leading biopharma clients across clinical development and safety operations.
Access career growth, skill development, and specialized training opportunities.
Be part of a diverse, inclusive, and innovative workplace culture.
Work in an environment that values quality, accountability, and patient-focused outcomes.
At Syneos Health, your work matters everywhere—helping bring safe and effective therapies to patients worldwide.
Apply Now to join our Hyderabad office-based Pharmacovigilance team and advance your career in drug safety and clinical research.
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