Job Title:
Safety & Pharmacovigilance (PV) Coordinator
Location: IND-Gurugram
Job ID: 25101792
Updated: September 18, 2025
Company Overview – Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The company focuses on patient-centric clinical development while streamlining processes to improve efficiency and outcomes.
Key Highlights:
Operates in 110 countries with 29,000 employees.
Partnered with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, 200+ studies, 73,000 sites, and 675,000+ trial patients in the last 5 years.
Promotes career development, technical training, and peer recognition.
Emphasizes a diverse, inclusive, and authentic workplace through its Total Self culture.
Role Summary
The Safety & PV Coordinator is responsible for supporting pharmacovigilance activities and ensuring accurate and timely safety reporting for clinical trials and post-marketing programs.
Key Responsibilities
Monitor and route incoming information to the appropriate projects.
Record and track ICSR (Individual Case Safety Report) documentation per sponsor/customer requirements.
Redact patient-identifying information according to data protection, ICH GCP, and GVP guidelines.
Enter data into the safety database following company and sponsor-specific standards.
Maintain file creation, tracking, retention, and electronic/paper maintenance.
Manage translation processes for source documents as needed.
Assist with query follow-up, submission processes, daily workflow reconciliation, and literature screening.
Support coding of events, medical history, concomitant medications, and tests.
Assist in narrative writing and generation of timely, accurate safety reports per regulatory requirements.
Perform validation of xEVMPD product records and manual recoding of un-recoded product/substance terms.
Identify and manage duplicate ICSRs and activities related to SPOR/IDMP.
Ensure submission of documents to Trial Master File (TMF) and Pharmacovigilance System Master File as per SOPs.
Maintain knowledge of SOPs, Work Instructions, GCP, ICH, GVP modules, study/program plans, and drug development processes.
Participate in audits and foster constructive relationships with team members.
Apply safety reporting regulatory intelligence in all PV activities.
Candidate Profile / Skills
Education: Bachelor’s degree in life sciences, nursing, pharmacy, or equivalent experience.
Familiarity with Safety Database systems and medical terminology preferred.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, Visio, TeamShare, and internet tools.
Strong communication, interpersonal, organizational, and documentation skills.
Ability to prioritize multiple tasks, maintain attention to detail, and deliver accurate results.
Team-oriented with adaptability to dynamic work environments.
Additional Information
Tasks and responsibilities listed are not exhaustive; the company may assign other duties.
Equivalent skills or experience may be considered in lieu of formal qualifications.
Nothing in this description constitutes an employment contract.
Syneos Health is committed to ADA compliance and providing reasonable accommodations.
How to Apply
Apply directly via Syneos Health website.
Not ready to apply? Join the Talent Network to stay connected for future opportunities.
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