India's DMPLOI - Jobs & Networking App
Syneos Health is hiring for the position of Safety & PV Specialist I – Literature Case Processing in Gurgaon, Haryana, India. This opportunity is suitable for professionals with experience in Pharmacovigilance, Literature Case Processing, and Medical Literature Monitoring (MLM).
Job Details
Company: Syneos Health
Position: Safety & PV Specialist I – Literature Case Processing
Location: Gurgaon, Haryana, India
Experience: 2+ years
Department: Pharmacovigilance / Drug Safety
Qualification: M.Pharm / BDS / Pharm.D or equivalent
Key Responsibilities
The selected candidate will be responsible for supporting various pharmacovigilance and safety operations, including:
- Processing and tracking Individual Case Safety Reports (ICSRs) according to SOPs and project-specific safety plans.
- Performing literature screening and review for safety-related information.
- Evaluating ICSR data for completeness, accuracy and regulatory reportability.
- Entering and maintaining case information in safety databases.
- Performing coding of adverse events, medical history, concomitant medications and laboratory/test information.
- Preparing complete and accurate case narratives.
- Identifying missing information and raising follow-up queries as required.
- Supporting expedited safety reporting in accordance with applicable regulatory requirements.
- Maintaining safety tracking for assigned activities.
- Performing drug coding, MedDRA coding and drug dictionary maintenance.
- Validating and submitting xEVMPD product records, including MedDRA indication coding.
- Manually recoding un-recoded product and substance terms arising from ICSRs.
- Identifying and managing duplicate ICSRs.
- Supporting SPOR / IDMP-related activities.
- Conducting quality reviews of ICSRs.
- Ensuring relevant documentation is maintained in the TMF and Pharmacovigilance System Master File, where applicable.
- Participating in audits when required.
- Applying regulatory intelligence to safety reporting activities.
Eligibility Criteria
Candidates should have:
- 2+ years of experience in Literature Data Entry along with MLM (Medical Literature Monitoring) experience.
- A degree in M.Pharm, BDS, Pharm.D or equivalent.
- Knowledge of safety database systems and medical terminology.
- Good understanding of clinical trial processes across Phase II–IV and/or post-marketing safety requirements.
- Knowledge of ICH-GCP, GVP and Pharmacovigilance regulations.
- Proficiency in Microsoft Office, including Word, Excel and PowerPoint.
- Ability to work independently as well as collaboratively within a team.
- Strong written and verbal communication skills.
- Good organizational and multitasking abilities.
- High attention to detail, accuracy and ability to meet deadlines.
Skills Required
Pharmacovigilance | Literature Case Processing | Medical Literature Monitoring | ICSR Processing | MedDRA Coding | Drug Coding | Safety Databases | xEVMPD | SPOR / IDMP | Clinical Safety | GVP | ICH-GCP
📍 Location
Gurgaon, Haryana, India
Why Join Syneos Health?
Syneos Health is a global life sciences services organization working across drug development and commercialization. The company highlights opportunities for career development, technical and therapeutic-area training, peer recognition and progression, along with an inclusive working culture.
How to Apply
Interested and eligible candidates can search for the “Safety & PV Specialist I – Literature Case Processing” position at Syneos Health on LinkedIn or through the company’s careers portal and submit their application.
