Principal Safety & Pv Specialist (literature Cp & Review)
Syneos Health
Gurugram, Haryana, India
Literature case processing expertise
Safety database systems knowledge
Pharmacovigilance regulatory compliance
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success and improving patient outcomes
Job Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success and improving patient outcomes.
The role involves conducting systematic literature searches, extracting safety information, managing program deliverables, and ensuring compliance with global pharmacovigilance regulations.
The company fosters a Total Self culture that values diversity, career development, and a supportive work environment where employees can authentically be themselves.
Matching Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success and improving patient outcomes.
Skills & Requirements
Must-have
Literature case processing expertise
Safety database systems knowledge
Pharmacovigilance regulatory compliance
Systematic literature searching
Clinical trial safety knowledge
Team lead experience
Report generation and documentation
Nice-to-have
Strong communication skills
Ability to work independently and in teams
Organizational and prioritization skills
Detail oriented with high accuracy
Problem solving and troubleshooting
Proficiency in Microsoft Office Suite
Key Requirements
B.Pharm/M.Pharm/PharmD/BDS/BMS degree
Minimum 8 years literature case processing experience
Team lead experience required
Knowledge of ICH GCP, GVP, and safety regulations
Experience with clinical trial phases II-IV and post-marketing safety