Safety & Pharmacovigilance Specialist I
Location: Pune, 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 Organization
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization supporting pharmaceutical, biotechnology, and medical device companies across the full product lifecycle. With operations in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health delivers end-to-end clinical development, pharmacovigilance, and medical affairs solutions with a strong commitment to patient safety and regulatory excellence.
The organization’s patient-first Clinical Development model emphasizes operational efficiency, scientific rigor, and regulatory compliance to accelerate the delivery of innovative therapies worldwide.
Position Overview
The Safety & Pharmacovigilance Specialist I will support global drug safety operations by managing Individual Case Safety Reports (ICSRs) from clinical trials and/or scientific literature. This role is ideal for professionals with foundational pharmacovigilance experience who are seeking to expand their exposure to global safety systems, regulatory frameworks, and cross-functional clinical teams.
Key Responsibilities
Enter and maintain safety data in validated pharmacovigilance quality and tracking systems
Support end-to-end processing of ICSRs in compliance with SOPs and project-specific safety plans
Triage safety cases and assess data for accuracy, completeness, and regulatory reportability
Perform safety data entry into approved safety databases
Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and drug dictionaries
Prepare clear, concise, and compliant case narratives
Identify missing information, raise queries, and follow up to resolution
Assist in the preparation and submission of expedited safety reports within regulatory timelines
Maintain safety tracking documentation for assigned activities
Conduct literature screening and review for safety case identification
Support drug dictionary maintenance and MedDRA coding activities
Validate and submit xEVMPD product records, including appropriate indication coding
Perform manual recoding of uncoded product and substance terms from ICSRs
Identify and manage duplicate safety cases
Support SPOR / IDMP-related pharmacovigilance activities
Perform quality reviews of ICSRs to ensure compliance and data integrity
Ensure timely filing of documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with ICH-GCP, GVP, global safety regulations, SOPs, and Work Instructions
Collaborate effectively with internal teams, sponsors, and external stakeholders
Participate in audits and inspections as required
Apply global 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 operations
Exposure to clinical trial case processing and/or literature case processing is preferred
Skills & Competencies
Strong understanding of pharmacovigilance principles and drug safety workflows
Knowledge of clinical trial phases II–IV and/or post-marketing safety requirements
Familiarity with ICH-GCP, GVP, and global pharmacovigilance regulations
Hands-on experience with safety databases and medical terminology
Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and document management tools
Excellent written and verbal communication skills
Strong 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
Opportunity to work on global clinical and post-marketing pharmacovigilance programs
Exposure to regulated safety environments and international compliance standards
Strong focus on professional development, training, and career progression
Inclusive and diverse workplace culture supporting long-term career growth
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to diversity, equity, and inclusion. Candidates with relevant and transferable skills are encouraged to apply, even if their experience does not perfectly align with every requirement listed.
SEO & GPT Keywords:
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