Pharmacovigilance Jobs at Syneos Health | Apply for the Safety & PV Specialist – Literature Review Role
If you are looking for rewarding Pharmacovigilance Jobs, this opportunity under Syneos Careers offers an excellent platform to work with a leading global biopharmaceutical organization. Join Syneos Health as a Safety & PV Specialist (Literature Review) and contribute to Literature review processes, drug safety operations, MedDRA coding, ICSR handling, and regulatory compliance while advancing your professional growth in an innovative and collaborative environment.
Job Details
- Job Title: Safety & PV Specialist I (Literature Review)
- Location: Gurgaon, Haryana
About the Company
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With 29,000+ employees across 110 countries, the organization brings together clinical, medical, and commercial expertise to deliver impactful healthcare solutions. Through Syneos Careers, the company promotes career development, diversity, inclusivity, and a supportive environment where individuals thrive while contributing to the improvement of patient lives globally.
Job Description | Pharmacovigilance Jobs
This Safety & PV Specialist I (Literature Review) role involves handling global Pharmacovigilance operations, including Literature review, ICSR processing, MedDRA coding, safety database management, narrative preparation, duplicate management, xEVMPD submissions, SPOR/IDMP activities, and ensuring regulatory compliance in alignment with global PV guidelines.
Key Responsibilities
- Enter data into PVG systems and assist with ICSR processing
- Perform triage, validation, and regulatory evaluation of ICSR data
- Conduct Literature screening, MedDRA coding, and drug dictionary maintenance
- Prepare narrative summaries and ensure database accuracy
- Support expedited safety reporting and compliance with SOPs and GVP
- Handle xEVMPD product records and duplicate ICSR management
- Conduct SPOR/IDMP-related activities and quality review
- Maintain documentation in TMF and support audits
- Collaborate with internal and external teams professionally
Qualifications Required for Pharmacovigilance Jobs
- Bachelor’s degree in Pharmacy or equivalent
- Minimum 2+ years of Literature Review experience
- Experience in Literature Case Processing & Clinical Case Processing preferred
- Strong safety database knowledge and understanding of ICH GCP & GVP
- Excellent communication, organization, and multitasking abilities
- Proficiency in MS Office tools
