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Safety & Pv Coordinator

0-2 years
Not Disclosed
10 Sept. 22, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.

Learn more: Syneos Health


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.