PHARMAFull-time
Safety & PV Specialist I - Literature Case processing
By Admin · Pharmacovigilance & Drug Safety
DELHI NCR (IN)ONSITEPOSTED: 9/15/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE OVERVIEW
Pharmacovigilance role focused on literature case processing, ICSR handling, safety database activities, MedDRA coding, quality review and regulatory safety reporting.
ROLE DEFINITION & RESPONSIBILITIES
- •Enter and track ICSR information in PV quality systems
- •process and triage ICSRs according to SOPs and safety plans
- •evaluate ICSR completeness and reportability
- •enter and code safety data
- •prepare case narratives and resolve queries
- •maintain safety tracking
- •perform literature screening and drug coding
- •maintain drug dictionaries and MedDRA coding
- •validate and submit xEVMPD product records
- •manage duplicate ICSRs
- •support SPOR/IDMP activities
- •conduct ICSR quality reviews
- •maintain TMF and PSMF documentation
- •participate in audits and apply regulatory intelligence
Reporting Hierarchy: Not specified
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- M.Pharma, BDS, Pharm D or equivalent
- 2+ years of literature data entry experience with MLM
- safety database and medical terminology knowledge
- understanding of clinical trial processes and post-marketing safety requirements
- knowledge of ICH GCP, GVP and pharmacovigilance regulations
- Microsoft Office proficiency
- strong communication, organization and attention to detail
PREFERRED QUALIFICATIONS
- •Experience with pharmacovigilance safety databases
- •MedDRA
- •xEVMPD
- •SPOR/IDMP
- •literature screening
- •ICSR quality review
- •regulatory intelligence
REQUIRED VERIFIED SKILLS
Pharmacovigilance; ICSR processing; literature screening; safety databases; MedDRA coding; medical terminology; drug coding; regulatory reporting; xEVMPD; SPOR/IDMP; TMF; PSMF; GVP; ICH GCP
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Career development and progression; supportive line management; technical and therapeutic area training; peer recognition; total rewards program; inclusive work culture
No salary range is disclosed in the supplied posting.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a fully integrated life sciences services organization supporting drug development and commercialization and accelerating customer success.
TEAM SIZE: Large global enterprise
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Agile, collaborative and inclusive culture emphasizing professional development, problem solving, customer focus and patient impact
EXPECTED CAREER ROADMAP
Potential progression into Pharmacovigilance Specialist, Senior PV Specialist, PV Case Processing Lead and broader Drug Safety leadership roles.
APPLICATION ADVISORY
Emphasize 2+ years literature data entry/MLM experience, M.Pharma/BDS/Pharm D qualification, ICSR processing, MedDRA, safety databases, GVP/GCP and regulatory reporting knowledge.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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