HEALTHCAREFull-time
Principal Safety & PV Specialist (Literature CP & Review)
By Admin · Pharmacovigilance & Drug Safety
HYDERABAD (IN)ONSITEPOSTED: 9/16/2026
HEALTHCAREFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE OVERVIEW
Lead pharmacovigilance literature case processing, safety review, and team workflows as a Principal Safety & PV Specialist based in Gurugram or Hyderabad.
ROLE DEFINITION & RESPONSIBILITIES
- •Conduct systematic and ad-hoc literature searches in global biomedical databases (Embase, PubMed, Medline)
- •Extract and summarize key safety information from identified literature sources
- •Create and validate search strategies for pharmacovigilance purposes
- •Prepare Safety Management Plan and manage program deliverables
- •Process ICSRs, triage cases, evaluate completeness, and code events and medical history
- •Ensure distribution of required individual expedited and periodic reports
- •Act as a subject matter expert and mentor team members with troubleshooting
Reporting Hierarchy: Reports to Pharmacovigilance Manager / Director • Team size: 8-12
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharm/M.Pharm/PharmD/BDS/BMS degree
- Minimum 8 Years of experience in Literature Case processing along with team lead experience
- In-depth understanding of clinical trial processes across Phases II-IV and post-marketing safety requirements
- Strong knowledge of ICH GCP, GVP, and global drug regulations
- Proficiency in Microsoft Office Suite and safety database systems
PREFERRED QUALIFICATIONS
- •Experience in local literature searches and reviews
- •Familiarity with Trial Master File (TMF) and Pharmacovigilance System Master File management
REQUIRED VERIFIED SKILLS
Pharmacovigilance
Literature Search
ICSR
Medical Coding
Safety Management
GVP
ICH GCP
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health insurance, provident fund, career progression programs, technical and therapeutic training, professional development
Competitive compensation benchmarked against senior pharmacovigilance and drug safety leadership roles in India.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Committed to building an inclusive culture where you can authentically be yourself and drive progress for patients in need.
EXPECTED CAREER ROADMAP
Career growth opportunities include Senior Manager - Pharmacovigilance, Associate Director of Safety Services, or Head of PV Operations.
APPLICATION ADVISORY
Highlight your extensive experience in literature case processing, search strategy creation, and team leadership in your application.
SPONSORED · TRAINING
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