Safety & Pharmacovigilance Specialist I
Location: Hyderabad, India
Job ID: 25104799
Employment Type: Full-Time
Job Category: Pharmacovigilance | Drug Safety | Clinical Research
Experience Required: Minimum 2 Years
Last Updated: January 20, 2026
About the Company
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success across the clinical development and commercialization lifecycle. Operating in over 110 countries with a workforce of more than 29,000 professionals, Syneos Health delivers integrated clinical development, pharmacovigilance, and medical affairs services to pharmaceutical, biotechnology, and medical device companies worldwide.
With a strong patient-centric approach, Syneos Health continuously simplifies and streamlines clinical and safety operations to ensure regulatory compliance, data integrity, and faster delivery of innovative therapies.
Job Overview
The Safety & Pharmacovigilance Specialist I will support global pharmacovigilance operations through accurate processing, documentation, and reporting of Individual Case Safety Reports (ICSRs) originating from clinical trials and/or scientific literature. This role is ideal for early-career pharmacovigilance professionals seeking hands-on exposure to global safety systems, regulatory standards, and cross-functional collaboration.
Key Responsibilities
Enter, review, and maintain safety case data in validated pharmacovigilance tracking and quality systems
Assist with 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 approved safety databases
Code adverse events, medical history, concomitant medications, and test results using MedDRA and drug dictionaries
Prepare high-quality case narratives and documentation
Identify missing information, raise queries, and follow up until satisfactory resolution
Support timely preparation and submission of expedited safety reports in line with global regulatory timelines
Maintain safety tracking records for assigned activities
Conduct literature screening and review for adverse event identification
Support drug dictionary maintenance and MedDRA coding activities
Validate and submit xEVMPD product records, including indication coding
Perform manual recoding of uncoded product and substance terms from ICSRs
Identify, assess, and manage duplicate safety cases
Support SPOR / IDMP-related pharmacovigilance activities
Perform quality checks and reviews of ICSRs
Ensure accurate and 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 teams, sponsors, and external stakeholders
Participate in audits and inspections as required
Apply regulatory intelligence and updates 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 operations
Exposure to clinical trial case processing and/or literature case processing is preferred
Skills & Competencies
Strong foundational knowledge of pharmacovigilance and drug safety processes
Understanding of clinical trial phases II–IV and/or post-marketing safety requirements
Working knowledge of ICH-GCP, GVP, and global pharmacovigilance regulations
Experience with safety databases and medical terminology
Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and document management tools
Strong written and verbal communication skills
Excellent organizational and time management abilities
High attention to detail with the ability to meet strict regulatory deadlines
Ability to work independently as well as collaboratively within cross-functional teams
Why Join Syneos Health
Opportunity to work on global clinical and post-marketing pharmacovigilance programs
Exposure to high-impact drug safety and regulatory compliance projects
Structured training, career development, and progression opportunities
Inclusive, diverse, and collaborative global work environment
Equal Opportunity Statement
Syneos Health is committed to building a diverse and inclusive workplace. Candidates with transferable skills and relevant experience are encouraged to apply, even if they do not meet every requirement listed.
SEO & GPT Keywords:
Safety & PV Specialist I Jobs, Pharmacovigilance Jobs Hyderabad, Drug Safety Jobs India, ICSR Processing Jobs, Entry Level Pharmacovigilance Roles, Clinical Trial Safety Jobs, Syneos Health Careers India
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