Pharma Job Opportunity at Syneos Health | PV Specialist Role | Apply Now
Looking for a Pharmacovigilance Job or a rewarding Pharma Job in India? This opportunity at Syneos Health for the role of Safety & PV Specialist is ideal for life science graduates and professionals with experience in drug safety and clinical research. Explore this Pharmacovigilance Job and Pharma Job to build your career in safety reporting, regulatory compliance, and global clinical research.
- Position: Safety & PV Specialist (Future Role)
- Location: India
About the Company
Syneos Health is a global, fully integrated biopharmaceutical solutions organization that helps pharmaceutical, biotechnology, and medical device companies accelerate the development and commercialization of new therapies. The company combines clinical research, medical affairs, and commercial expertise to deliver end-to-end solutions across the entire drug development lifecycle.
Job Description
- This is a pipeline opportunity for upcoming roles, not an active position
- Candidates will be added to the talent pool for future openings
Role Overview:
- Provide expertise in pharmacovigilance and safety services
- Participate in medical safety activities for clinical trials
- Perform medical review and clarification of adverse events
- Support aggregate safety data review and reporting
- Act as an internal consultant for pharmacovigilance case processing
- Contribute to safety signal detection and risk management
- Provide safety support to clinical development teams
Impact & Contribution:
- Individual contributor role in a professional/technical discipline
- May guide junior professionals or manage processes
- Involved in the design, implementation, and delivery of processes/programs
- Work on smaller and less complex projects
- Requires theoretical knowledge through education or prior experience
Key Responsibilities
- Enter and track ICSR data in PVG systems
- Process ICSRs as per SOPs and safety plans
- Review ICSRs for completeness, accuracy, and compliance
- Perform data entry, coding (MedDRA), and narrative writing
- Follow up on queries and ensure proper resolution
- Support expedited safety reporting as per regulations
- Maintain safety tracking and documentation
- Conduct literature screening and drug coding activities
- Handle xEVMPD submissions and product coding
- Identify and manage duplicate ICSRs
- Perform quality review of safety data
- Ensure proper filing in TMF and safety databases
- Maintain compliance with GCP, ICH, GVP, and regulatory guidelines
- Collaborate with internal and external teams
- Participate in audits and apply regulatory intelligence
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field
- Basic knowledge of safety databases and medical terminology
- Understanding of clinical trials (Phase II–IV) and pharmacovigilance regulations (ICH GCP, GVP)
- Proficiency in MS Office tools (Word, Excel, PowerPoint, Outlook)
- Ability to work independently and as part of a team
- Good communication and interpersonal skills
- Strong organizational and multitasking abilities
- Detail-oriented with accuracy and ability to meet deadlines
