Safety & PV Submission Specialist II
Location: Gurugram / Hyderabad, India
Employment Type: Full-Time
Company: Syneos Health
Position Summary
The Safety & PV Submission Specialist II is responsible for managing and coordinating safety reporting and pharmacovigilance submission activities across clinical and post-marketing programs. The role ensures timely and compliant submissions of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees, Investigators, and Sponsors while maintaining adherence to global pharmacovigilance regulations, ICH guidelines, GCP standards, and company procedures.
The position serves as a key point of contact for safety submission activities and supports project management, compliance oversight, audit readiness, and pharmacovigilance documentation management.
Key Responsibilities
Safety Submission Management
Coordinate preparation, review, and submission of expedited and periodic safety reports.
Manage end-to-end safety submission activities across clinical trials and post-marketing programs.
Ensure submission timelines meet global regulatory requirements.
Maintain submission trackers and reporting dashboards.
Monitor submission status and resolve delays proactively.
Regulatory Safety Reporting
Prepare and submit:
SUSAR Reports
CIOMS Reports
Expedited Safety Reports
Periodic Safety Reports
DSUR (Development Safety Update Reports)
PSUR/PBRER Submissions
Line Listings and Safety Narratives
Ensure compliance with global and local reporting requirements.
Project & Sponsor Support
Collaborate with Sponsors and project teams during project initiation and execution.
Participate in project launch activities for safety reporting.
Develop Safety Reporting Plans for assigned projects.
Provide regular submission status updates to Sponsors and stakeholders.
Act as SME for safety submission-related issues.
Regulatory Intelligence & Compliance
Apply global pharmacovigilance regulatory intelligence to submission activities.
Monitor evolving regulatory requirements.
Ensure compliance with:
FDA Regulations
EMA Requirements
MHRA Guidelines
CDSCO Regulations
ICH Guidelines
GCP Standards
Support implementation of regulatory updates.
TMF & Documentation Management
Ensure timely filing of safety-related documents.
Maintain Trial Master File (TMF) documentation.
Support Pharmacovigilance System Master File (PSMF) documentation activities.
Maintain inspection-ready documentation.
Ensure document version control and archival compliance.
Safety Operations Oversight
Track submission metrics and KPIs.
Generate operational reports and compliance dashboards.
Support workload planning and task allocation.
Identify process improvement opportunities.
Contribute to operational excellence initiatives.
Audit & Inspection Support
Participate in internal audits and external inspections.
Support audit preparation and response activities.
Ensure inspection readiness of submission records.
Assist with CAPA implementation and compliance follow-up.
Stakeholder Management
Serve as primary contact for safety submission issues.
Coordinate with:
Sponsors
Regulatory Authorities
Ethics Committees
Clinical Teams
Pharmacovigilance Teams
Regulatory Affairs Teams
Build strong working relationships across functions.
Quality & Compliance
Ensure adherence to:
SOPs
Work Instructions (WIs)
Company Policies
Global Regulatory Requirements
Maintain quality standards for all submission deliverables.
Support continuous process improvement initiatives.
Educational Qualification
Required
Bachelor's Degree in:
Life Sciences
Pharmacy
Nursing
Healthcare Sciences
Related Scientific Discipline
Preferred
B.Pharm / M.Pharm
PharmD
Registered Nurse (RN)
Master's Degree in Life Sciences
Experience Required
Minimum 4+ years of Pharmacovigilance experience.
Experience in:
Safety Submissions
Regulatory Reporting
Pharmacovigilance Operations
Clinical Safety
Drug Safety Reporting
Experience in CRO environment preferred.
Experience handling submissions to:
Regulatory Authorities
Ethics Committees
Investigators
Sponsors
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