Syneos Health Hiring Safety & PV Submission Specialist | Apply Today
Looking for a Pharmacovigilance Job with a globally recognized CRO? Syneos Health Careers has announced an excellent opportunity for the position of Safety & PV Submission Specialist I in Gurugram/Hyderabad (Hybrid). Candidates with a Bachelor’s degree in Pharmacy or related fields and at least two years of Pharmacovigilance experience are encouraged to apply. This Pharmacovigilance Job through Syneos Health Careers offers hands-on exposure to global safety submissions, regulatory compliance, and clinical research projects while providing outstanding career growth opportunities.
- Position: Safety & PV Submission Specialist
- Location: Gurugram/Hyderabad (hybrid)
About the Company
Syneos Health® is a leading fully-integrated life sciences services organization dedicated to accelerating customer success. The company partners with innovators throughout the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. With more than 25,000 employees worldwide, Syneos Health Careers provides professionals with opportunities to contribute to innovative healthcare solutions and global clinical research programs.
Job Description
Syneos Health is hiring a Safety & PV Submission Specialist I to support global safety reporting and pharmacovigilance activities. This Pharmacovigilance Job involves preparing, managing, and submitting expedited and periodic safety reports while ensuring compliance with ICH GCP, GVP, SOPs, and international regulatory requirements.
Key Responsibilities
- Collaborate with the Sponsor and internal project management associates on the design, preparation, and assembly of the expedited and periodic safety report documents.
- Participate in project launch activities for safety reporting tasks.
- Prepare Safety Reporting Plan for safety submissions-only projects.
- Maintain tracking of safety submissions.
- Provide Sponsor/Customer with expedited and periodic safety report submission status updates.
- Support expedited and periodic safety report issues for project teams and sponsors.
- Apply safety reporting regulatory intelligence maintained by Syneos Health.
- File documents according to project-specific requirements.
- Forward completed safety submission documents to clients and relevant parties.
- Act as a point of contact for regulatory issues related to safety submissions.
- Monitor and distribute team workload where applicable.
- Participate in project review meetings and audits.
- Ensure Trial Master File (TMF) and Pharmacovigilance System Master File documentation compliance.
- Maintain compliance with SOPs, Work Instructions, ICH Guidelines, GCP, GVP, and global regulations.
Qualifications
- Bachelor’s Degree in Life Science, Pharmacy, Nursing, or equivalent qualification.
- Minimum 2 years of Safety and Pharmacovigilance experience.
- Clinical Research Organization experience preferred.
- Experience in Safety Submissions to Regulatory Authorities, Ethics Committees, and Sites.
- TMF Filing and oversight experience.
- Knowledge of PV guidelines, FDA, EMEA, and India regulations.
- Safety Database systems experience.
- Strong understanding of ICH GCP, GVP, and clinical trial processes.
- Proficiency in Microsoft Office Suite.
- Excellent communication and organizational skills.
- Ability to work independently and within a team.
- Willingness to travel up to 5%.
Why Choose this Role?
- Hybrid work opportunity.
- Career development and professional growth.
- Global clinical research exposure.
- Inclusive workplace culture.
- Technical and therapeutic area training.
- Opportunity to work on innovative drug development projects.
