Syneos Health is hiring for the position of Safety & PV Specialist I – Literature Review in Gurugram, India. This opportunity is suitable for candidates with a Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline who have relevant knowledge and skills in pharmacovigilance, drug safety, literature review, ICSR processing, and safety databases.
The Syneos Health Pharmacovigilance job in Gurugram involves literature screening, ICSR processing, safety database activities, MedDRA coding, drug coding, duplicate case management, quality review, and regulatory safety reporting.
Candidates seeking careers in pharmacovigilance, drug safety, ICSR case processing, literature review, MedDRA coding, and clinical safety can review the eligibility requirements and application process below.
About Syneos Health
Syneos Health is a global, fully integrated life sciences services organization supporting pharmaceutical and biotechnology companies across drug development and commercialization.
Its Clinical Solutions teams work across multiple areas of clinical development, helping customers manage complex clinical research and drug development programs.
According to the information provided with this vacancy, Syneos Health has worked with a substantial proportion of novel FDA-approved drugs and EMA-authorized products and has supported studies across thousands of clinical research sites worldwide.
Job Responsibilities
As a Safety & PV Specialist I – Literature Review, the selected candidate may be responsible for:
- Entering safety information into pharmacovigilance quality and tracking systems for the receipt and tracking of Individual Case Safety Reports (ICSRs).
- Assisting with ICSR processing according to applicable SOPs and project-specific safety plans.
- Performing ICSR triage and evaluating safety information for completeness, accuracy, and regulatory reportability.
- Entering relevant case information into safety databases.
- Coding adverse events, medical history, concomitant medications, tests, and other relevant medical information.
- Preparing complete and accurate safety case narratives.
- Identifying missing information and generating follow-up queries when required.
- Supporting timely and accurate submission of expedited safety reports according to regulatory requirements.
- Maintaining safety tracking documentation for assigned activities.
- Performing literature screening and literature review for pharmacovigilance.
- Performing drug coding and maintaining drug dictionaries.
- Conducting MedDRA coding when required.
- Supporting validation and submission of xEVMPD product records, including MedDRA coding of indication terms.
- Performing manual recoding of un-recoded product and substance terms arising from ICSRs.
- Identifying and managing duplicate ICSRs.
- Supporting activities related to SPOR and IDMP.
- Performing quality review of ICSRs.
- Ensuring relevant clinical safety documents are submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF), as applicable.
- Maintaining compliance with SOPs, work instructions, ICH guidelines, GCP, GVP, global safety regulations, and project requirements.
- Supporting audits when required.
- Applying applicable safety-reporting regulatory intelligence to pharmacovigilance activities.
- Maintaining professional working relationships with internal and external project stakeholders.
Educational Qualifications
Candidates should have:
Bachelor’s Degree in Life Sciences, Pharmacy, Nursing, or another relevant discipline, or an equivalent combination of education and experience.
Relevant educational backgrounds may include B.Pharm, Pharm.D, B.Sc Nursing, B.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, or other closely related life science disciplines, subject to Syneos Health’s assessment of equivalency.
Candidates with higher relevant qualifications may also consider applying where their education and experience align with the role requirements.
Skills Required for Safety & PV Specialist I
Candidates should possess knowledge or experience in areas such as:
- Pharmacovigilance and drug safety
- ICSR processing
- Literature screening and review
- Safety databases
- Medical terminology
- MedDRA coding
- Drug coding and drug dictionaries
- Safety case narratives
- Expedited safety reporting
- Clinical trial safety
- Post-marketing pharmacovigilance
- ICH-GCP and GVP
- Phase II–IV clinical trial processes
- Safety regulations
- Microsoft Word, Excel and PowerPoint
- Documentation and quality review
- Time and priority management
Knowledge of xEVMPD, SPOR, IDMP, TMF and PSMF activities may also be relevant to the position.
Why Consider This Pharmacovigilance Role?
Syneos Health highlights employee development and career progression as important components of its work environment.
Potential professional advantages described by the company include:
- Career development and progression opportunities
- Technical and therapeutic-area training
- Supportive line management
- Peer recognition programs
- Exposure to global drug development and pharmacovigilance activities
- Collaboration with multidisciplinary life sciences teams
- Experience working with clinical and post-marketing safety processes
Benefits and employment terms may vary according to company policy, location, and individual employment conditions.
Who Should Apply?
This position may be particularly relevant for professionals building careers in:
Pharmacovigilance | Drug Safety | Literature Review | ICSR Processing | Safety Case Processing | Medical Coding | MedDRA Coding | Clinical Safety | Safety Database Operations
Applicants should carefully compare their qualifications and experience against the official Syneos Health job requirements before applying.
Job Location
Gurugram, India
The vacancy is listed as an office-based, full-time position.
How to Apply
