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Safety & Pv Specialist I (Review Of Literature Cases)

2+ years
₹5,00,000 – ₹8,00,000 per annum
10 Aug. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety & PV Specialist I – Review of Literature Cases
Location: Gurugram, India

Company Overview:
Syneos Health® is a leading global biopharmaceutical solutions provider, integrating clinical, medical affairs, and commercial capabilities to accelerate drug development and delivery. With more than 29,000 employees in over 110 countries, Syneos partners with leading pharmaceutical and biotech companies to bring innovative therapies to patients faster.

Why Join Syneos Health:

  • Career progression through structured training and mentorship.

  • A “Total Self” culture that encourages authenticity and belonging.

  • Access to therapeutic and technical learning opportunities.

  • Recognition programs and competitive rewards.

  • Inclusive, collaborative, and purpose-driven work environment.

Key Responsibilities:

  • Conduct systematic and ad-hoc literature searches in biomedical databases (e.g., Embase, PubMed, Medline) to identify Individual Case Safety Reports (ICSRs) and safety-relevant data.

  • Extract, summarize, and validate safety information for pharmacovigilance (PV) purposes.

  • Create and maintain search strategies for global and local literature monitoring.

  • Process ICSRs in accordance with SOPs and project-specific safety plans, including data entry, coding (MedDRA), and narrative writing.

  • Validate and submit xEVMPD product records, ensuring accurate coding of indications.

  • Identify and manage duplicate ICSRs, perform drug coding, and maintain drug dictionaries.

  • Ensure compliance with ICH GCP, GVP, and global safety regulations for clinical trial and post-marketing activities.

  • Maintain accurate safety tracking and ensure timely submission of regulatory reports.

  • Participate in audits, apply regulatory intelligence, and ensure quality control of deliverables.

  • Collaborate effectively with cross-functional teams, maintaining professional working relationships.

Qualifications:

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (or equivalent experience).

  • Strong understanding of medical terminology, pharmacovigilance processes, and clinical trial phases (II–IV).

  • Proficiency with safety database systems and Microsoft Office Suite.

  • Familiarity with global safety reporting regulations, ICH guidelines, and MedDRA coding.

  • Strong organizational skills, detail orientation, and ability to manage multiple projects.

  • Excellent written and verbal communication skills.

Salary Range: ₹5,00,000 – ₹8,00,000 per annum (estimated industry standard for entry to mid-level PV roles in India).