Safety & Pharmacovigilance Specialist II
(Literature or Clinical Trial Case Processing)
Location: Gurugram, India
Additional Location: Hyderabad, India
Job ID: 25104809
Job Type: Full-Time
Function: Pharmacovigilance / Drug Safety / Clinical Research
Industry: Biopharmaceutical / CRO
Last Updated: January 20, 2026
About Syneos Health
Syneos Health® is a global biopharmaceutical solutions organization committed to accelerating the delivery of life-changing therapies. With operations across more than 110 countries, Syneos Health integrates clinical development, pharmacovigilance, and medical affairs expertise to support innovative research and regulatory excellence worldwide.
Driven by a patient-centric model, Syneos Health fosters a collaborative and inclusive culture where scientific rigor, quality, and professional growth are central to success.
Position Overview
The Safety & Pharmacovigilance Specialist II will be responsible for end-to-end processing of Individual Case Safety Reports (ICSRs) originating from clinical trials and/or scientific literature. This role ensures accurate case evaluation, regulatory compliance, and high-quality safety data management in accordance with global pharmacovigilance standards.
The position requires hands-on experience in clinical trial or literature case processing, strong pharmacovigilance knowledge, and familiarity with global safety regulations.
Key Responsibilities
Perform end-to-end processing of ICSRs in accordance with SOPs and project-specific safety plans
Triage and evaluate case data for completeness, accuracy, and regulatory reportability
Enter and maintain safety data within validated safety databases
Code adverse events, medical history, concomitant medications, and laboratory data using MedDRA and drug dictionaries
Prepare comprehensive and medically accurate narrative case summaries
Identify missing or unclear information, generate queries, and follow up to resolution
Support timely submission of expedited safety reports in line with global regulatory requirements
Conduct literature screening and review for safety reporting
Perform xEVMPD product record validation and submission, including MedDRA indication coding
Support SPOR / IDMP-related activities and manual recoding of product and substance terms
Identify and manage duplicate safety cases
Conduct quality review of ICSRs and associated documentation
Ensure appropriate filing of documents within the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with global pharmacovigilance regulations, including ICH-GCP, GVP, and applicable local requirements
Participate in audits and inspections as required
Collaborate effectively with internal teams, sponsors, and external stakeholders
Required Qualifications & Experience
Education
Bachelor’s or Master’s degree in Pharmacy or Life Sciences
Accepted qualifications include B.Pharm, M.Pharm, PharmD, or BDS
Experience
Minimum 3.5 years of experience in pharmacovigilance
Mandatory experience in clinical trial case processing or literature case processing
Demonstrated hands-on experience with ICSR processing and safety databases
Technical & Professional Skills
Strong understanding of pharmacovigilance processes and global safety regulations
Knowledge of clinical trial phases II–IV and post-marketing safety requirements
Proficiency in MedDRA coding, drug dictionaries, and medical terminology
Experience with safety database systems (ARGUS or equivalent preferred)
Familiarity with ICH-GCP, GVP, and international regulatory requirements
Proficiency in Microsoft Office applications and shared content management platforms
Strong attention to detail with the ability to meet strict timelines
Excellent written and verbal communication skills in English
Ability to work independently and within cross-functional teams
Why Join Syneos Health?
Work with a global organization supporting the majority of newly approved FDA and EMA products
Exposure to diverse pharmacovigilance programs across clinical and post-marketing settings
Access to structured career development, technical training, and mentoring
Inclusive, collaborative workplace culture focused on quality, integrity, and growth
Equal Opportunity Statement
Syneos Health is committed to fostering a diverse and inclusive workforce. Qualified candidates are encouraged to apply even if their experience does not perfectly align, as transferable skills are valued.
SEO & GPT Optimization Keywords:
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