Safety & Pharmacovigilance Specialist I
Locations: Gurugram / Hyderabad, India
Job ID: 25104799-OTHLOC-5448
Last Updated: January 20, 2026
Work Mode: On-site
About the Company
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success. With deep expertise across clinical development, medical affairs, and commercial solutions, Syneos Health translates scientific and operational insights into meaningful patient outcomes.
With a presence in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health supports innovation across the entire drug development lifecycle. The organization is known for its patient-centric approach, agile delivery models, and commitment to quality, compliance, and diversity.
Job Overview
The Safety & Pharmacovigilance Specialist I will support end-to-end pharmacovigilance activities, including Individual Case Safety Report (ICSR) processing, literature surveillance, safety database management, and regulatory reporting. This role is ideal for professionals with hands-on experience in clinical trial and/or post-marketing safety operations who are looking to advance their career within a global PV environment.
Key Responsibilities
Perform receipt, triage, processing, and tracking of ICSRs in pharmacovigilance quality and safety databases in compliance with SOPs and project-specific safety plans
Review ICSRs for data completeness, accuracy, medical consistency, and regulatory reportability
Enter and code adverse events, medical history, concomitant medications, tests, and indications using MedDRA and WHO Drug dictionaries
Compile clear, accurate, and compliant case narratives
Identify missing or inconsistent information, generate queries, and ensure timely resolution
Support the preparation and submission of expedited safety reports in accordance with global regulatory requirements
Maintain safety tracking logs and documentation for assigned activities
Conduct literature screening and case processing as required
Perform xEVMPD product record validation and submission, including MedDRA-coded indication terms
Support SPOR / IDMP-related pharmacovigilance activities
Identify and manage duplicate ICSRs
Conduct quality review of safety cases
Ensure timely submission of all safety-related documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP, global regulatory requirements, and internal quality standards
Participate in internal and external audits as required
Collaborate effectively with cross-functional teams, sponsors, and internal stakeholders
Qualifications
Education: B.Pharm / M.Pharm / PharmD / BDS
Experience: Minimum 2 years of hands-on experience in Pharmacovigilance or Drug Safety
Required Skills & Competencies
Proven experience in ICSR case processing and/or literature case processing
Strong working knowledge of pharmacovigilance regulations, including ICH-GCP, GVP, and global safety reporting requirements
Familiarity with clinical trial phases (II–IV) and post-marketing safety activities
Experience with safety databases and medical terminology
Knowledge of MedDRA coding, drug dictionaries, and regulatory reporting workflows
Understanding of xEVMPD, SPOR, and IDMP concepts is an advantage
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook)
Strong written and verbal communication skills
Excellent organizational skills with the ability to manage multiple tasks and meet deadlines
Detail-oriented with a high degree of accuracy
Ability to work both independently and collaboratively in a global team environment
Why Join Syneos Health
Work on programs supporting a majority of FDA- and EMA-approved novel drugs
Exposure to global clinical trials and post-marketing safety programs
Strong focus on career development, technical training, and professional growth
Inclusive work culture that values diversity, integrity, and collaboration
Opportunity to contribute to life-changing therapies in a highly regulated and impactful domain
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to fostering an inclusive workplace. Employment decisions are based on qualifications, merit, and business needs. Reasonable accommodations will be provided in accordance with applicable laws.
Apply now on thepharmadaily.com to advance your career in Pharmacovigilance and Drug Safety with a global biopharmaceutical leader.
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