Safety & Pharmacovigilance Specialist I
(Gurugram / Hyderabad)
Location: Gurugram or Hyderabad, India
Job ID: 25104799
Employment Type: Full-Time
Job Function: Pharmacovigilance | Drug Safety | Clinical Research
Experience Required: Minimum 2 Years
Last Updated: January 20, 2026
About Syneos Health
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating the development and delivery of innovative therapies. With operations spanning over 110 countries and a workforce of more than 29,000 professionals, Syneos Health combines clinical development, pharmacovigilance, and medical affairs expertise to support pharmaceutical and biotechnology partners worldwide.
The organization’s patient-centric Clinical Development model emphasizes quality, compliance, and operational excellence, ensuring faster and safer delivery of therapies across the product lifecycle.
Job Overview
The Safety & Pharmacovigilance Specialist I will support pharmacovigilance operations through accurate and timely processing of Individual Case Safety Reports (ICSRs) arising from clinical trials and/or scientific literature. This role is ideal for early to mid-level pharmacovigilance professionals seeking hands-on experience in global drug safety processes, regulatory compliance, and safety data management.
Key Responsibilities
Enter and maintain ICSR data in pharmacovigilance quality and safety tracking systems
Assist in end-to-end processing of ICSRs in accordance with SOPs and project-specific safety plans
Triage safety cases and assess data for completeness, accuracy, and regulatory reportability
Perform safety data entry into validated safety databases
Code adverse events, medical history, concomitant medications, and laboratory data using MedDRA and drug dictionaries
Compile clear and accurate case narratives
Identify missing information, raise queries, and follow up until resolution
Support preparation and submission of expedited safety reports within regulatory timelines
Maintain safety tracking logs for assigned activities
Conduct literature screening and review for safety reporting
Perform MedDRA coding and drug dictionary maintenance
Validate and submit xEVMPD product records, including indication coding
Perform manual recoding of un-coded product and substance terms from ICSRs
Identify and manage duplicate safety cases
Support SPOR / IDMP-related activities
Conduct quality reviews of ICSRs
Ensure timely filing of documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP, and global safety regulations
Collaborate effectively with internal and external project stakeholders
Participate in audits and inspections as required
Apply regulatory intelligence to daily pharmacovigilance activities
Required Qualifications
Education:
Bachelor’s or Master’s degree in Pharmacy or Life Sciences
Accepted qualifications: B.Pharm, M.Pharm, PharmD, BDS
Experience:
Minimum 2 years of experience in pharmacovigilance or drug safety
Prior exposure to clinical trial case processing or literature case processing is preferred
Skills & Competencies
Foundational knowledge of pharmacovigilance processes and safety regulations
Understanding of clinical trial phases II–IV and/or post-marketing safety requirements
Working knowledge of ICH-GCP, GVP, and global pharmacovigilance guidelines
Experience with safety database systems and medical terminology
Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and document management systems
Strong written and verbal communication skills
Good organizational and time management abilities
High attention to detail with the ability to meet regulatory deadlines
Ability to work independently and collaboratively within cross-functional teams
Why Join Syneos Health?
Exposure to global pharmacovigilance programs across clinical and post-marketing settings
Opportunity to work on a broad range of innovative and regulatory-compliant drug development projects
Strong emphasis on professional development, training, and career progression
Inclusive and diverse workplace culture that values collaboration and innovation
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to fostering a diverse and inclusive workplace. Candidates with transferable skills and relevant experience are encouraged to apply, even if all requirements are not fully met.
SEO & GPT Optimization Keywords:
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