Sr Safety & Pv Specialist (literature Case Processing & Review)
Syneos Health
Gurugram, India
Literature case processing expertise
Pharmacovigilance literature search
Safety database systems knowledge
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success and improve patient outcomes
Job Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success and improve patient outcomes.
The role involves conducting systematic literature searches, processing ICSRs, ensuring regulatory compliance, and supporting project delivery in pharmacovigilance.
The company fosters a Total Self culture focused on diversity, inclusion, career development, and creating a workplace where everyone feels they belong.
Matching Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success and improve patient outcomes.
Skills & Requirements
Must-have
Literature case processing expertise
Pharmacovigilance literature search
Safety database systems knowledge
Clinical trial safety knowledge
Regulatory compliance in pharmacovigilance
Data entry and coding of ICSRs
Microsoft Office proficiency
Nice-to-have
Strong communication and presentation skills
Ability to work independently and in teams
Organizational and prioritization skills
Detail oriented with high accuracy
Subject matter expert support
Experience with audits and inspections
Training investigators on ICSR reporting
Key Requirements
B.Pharm/M.Pharm/PharmD/BDS/BMS degree
Minimum 5 years literature case processing experience
SME experience in pharmacovigilance
Knowledge of ICH GCP, GVP, and safety regulations
Experience with clinical trial phases II-IV and post-marketing safety