Life Sciences PV Job at Syneos Health, Apply Now For Safety & PV Specialist Role
Looking to build a global career in drug safety and pharmacovigilance documentation or a Life Sciences PV Job? Join Syneos Health as a Safety & PV Specialist I, where you’ll play a vital role in ensuring patient safety and regulatory compliance across worldwide clinical programs. This is an excellent opportunity for life science professionals seeking to advance in pharmacovigilance documentation jobs while contributing to the development of life-changing therapies. Work with an industry leader committed to innovation, collaboration, and transforming the future of healthcare.
- Job Title: Safety & PV Specialist I
- Location: Remote/Hybrid (IND-Gurugram)
- Employment Type: Full-time
- Job Requisition ID: 25999935
About The Company
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do.
Role Overview
Join Syneos Health as a Safety & PV Specialist I and play a pivotal role in global pharmacovigilance and safety documentation activities. This position offers the opportunity to contribute to drug safety operations, literature review, and regulatory compliance across diverse therapeutic areas.
Key Responsibilities
- Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline).
- Extract, analyze, and summarize safety-related data for case processing and documentation.
- Develop and validate search strategies for pharmacovigilance purposes.
- Perform local and global literature reviews for ICSR identification and regulatory reporting.
- Enter and track ICSR information in pharmacovigilance databases.
- Evaluate, code, and compile case narratives and safety summaries.
- Support pharmacovigilance documentation activities including MedDRA coding, xEVMPD submissions, and quality reviews.
- Maintain compliance with SOPs, GVP, ICH guidelines, and regulatory reporting requirements.
- Participate in internal and external audits as required.
- Ensure all documentation is filed in TMF or PV System Master File as per regulatory standards.
Qualification Requirements
- Bachelor’s Degree in Life Sciences, Pharmacy, or Nursing, or equivalent qualification.
- Proven knowledge of safety databases, pharmacovigilance documentation, and medical terminology.
- Understanding of clinical trial phases (II–IV) and post-marketing safety reporting.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and safety documentation systems.
- Strong organizational and multitasking abilities with attention to detail.
- Excellent communication, teamwork, and time management skills.
Why Join Syneos Health
- Work on pharmacovigilance documentation jobs that directly impact global drug safety.
- Gain exposure to international regulatory frameworks and clinical operations.
- Be part of a Total Self Culture that values authenticity, inclusion, and personal growth.
- Continuous learning through career development programs, peer recognition, and global exposure.
