PHARMAFull-time
Safety & PV Submission Specialist I
HYDERABAD (IN)HYBRIDPOSTED: 7/3/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
As a Safety & PV Submission Specialist I, you will
Prepare expedited and periodic safety reports.
Coordinate safety submission activities with sponsors and project teams.
Develop Safety Reporting Plans.
Maintain safety submission trackers and documentation.
Submit safety reports to Regulatory Authorities, Ethics Committees, and Clinical Sites.
Support Trial Master File (TMF) documentation.
Ensure compliance with ICH GCP, GVP, FDA, EMA, and Indian Pharmacovigilance guidelines.
Monitor project timelines and submission metrics.
Participate in audits and quality inspections.
Act as the primary contact for safety submission regulatory issues.
Maintain accurate documentation according to SOPs and project requirements.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
Safety Submissions
Regulatory Compliance
ICH GCP
GVP
FDA Guidelines
EMA Guidelines
TMF
COMPENSATION & REWARDS
₹7.0L - 11.0L per annum
The expected salary range for this role in India is ₹7,00,000 – ₹11,00,000 per annum (CTC), though actual compensation may vary based on individual experience, technical skills, and interview performance.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully integrated biopharmaceutical solutions organization. They provide end-to-end clinical and commercial solutions designed to accelerate the development and commercialization of new therapies worldwide. The company combines clinical development, medical affairs, and commercialization expertise to help clients bring innovative treatments to patients faster.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
EXPECTED CAREER ROADMAP
Syneos Health provides excellent career growth, global exposure, and opportunities to work on innovative clinical development projects, supporting 94% of recent FDA-approved novel drugs and 95% of EMA-authorized medicines.
APPLICATION ADVISORY
Highlight your hands-on experience with safety databases and regulatory submissions. Ensure your resume reflects familiarity with ICH GCP and GVP guidelines, as these are critical for compliance-focused roles at a global CRO.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.