HEALTHCAREFull-time
Principal Safety & PV Specialist (Literature CP & Review)
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.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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