Role Overview
This position focuses on the development, coordination, and submission of expedited and periodic safety reports in accordance with international regulatory requirements. The Senior Safety & PV Submission Specialist plays a key role in ensuring accurate and timely safety documentation across both clinical trials and post-market surveillance activities.
Key Responsibilities
- Work closely with sponsors and internal teams to design, draft, and finalize safety reports for global submissions
- Support project initiation activities related to safety reporting workflows and documentation planning
- Develop Safety Reporting Plans for projects focused solely on safety submissions
- Monitor and document all safety submission activities, ensuring traceability and compliance
- Provide regular updates to sponsors and stakeholders on submission status and timelines
- Offer guidance on safety reporting matters to project teams and external partners as needed
- Apply current regulatory intelligence to ensure all submissions meet evolving global standards
- Manage document filing in compliance with project-specific protocols, whether electronic or physical
- Distribute finalized safety reports to relevant recipients according to distribution plans
- Serve as a primary contact for regulatory questions concerning safety submissions
- Support workload distribution and oversight within the team when required
- Build and maintain professional relationships across departments and with external collaborators
- Contribute to internal project reviews and team performance tracking using cycle time and KPI data
- Participate in internal and external audits related to pharmacovigilance processes
- Ensure all submission documents are properly archived in the Trial Master File or Pharmacovigilance Master File as applicable
- Stay current with SOPs, Work Instructions, ICH guidelines, GCP, GVP, and global regulatory expectations
Required Qualifications
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related field, or equivalent professional experience
- Minimum of six years of hands-on experience in pharmacovigilance and safety reporting
- Proven experience preparing and submitting safety reports to regulatory bodies and ethics committees
- Familiarity with Trial Master File management and documentation standards
- Detailed knowledge of pharmacovigilance regulations from EMEA, FDA, and Indian authorities
- Experience with safety databases and fluency in medical terminology
- Understanding of clinical development phases II through IV and post-marketing safety requirements
- Proficiency in Microsoft Office (Word, Excel, PowerPoint), Visio, Outlook, and collaborative platforms
- Strong organizational and time management skills, with the ability to manage multiple priorities
- Excellent written and verbal communication abilities
- Capacity to make sound, independent decisions while working within a team structure
Preferred Experience
- Prior work within a clinical research organization (CRO) environment
Technical Environment
- Microsoft Office Suite (Word, Excel, PowerPoint, Visio)
- Email and collaboration tools (Outlook, TeamShare, or similar platforms)
- Safety database systems
- Internet-based research and regulatory portals
Work Location
This role is based locally in either Gurugram or Hyderabad, with minimal travel expected (up to 5%).
Company Culture
The organization emphasizes professional growth, inclusion, and operational agility. Team members are encouraged to contribute meaningfully to healthcare innovation, supported by engaged leadership and a culture that values authenticity and collaboration. The environment fosters continuous improvement and accountability in delivering high-quality outcomes for patients and clients.
