The pharmaceutical and clinical research industry continues to expand its safety and compliance workforce, and this Senior Safety Reporting Specialist job presents a compelling opportunity for experienced drug safety professionals. This role is fully remote, making it an excellent fit for candidates across India with strong expertise in pharmacovigilance safety reporting, regulatory submissions, and expedited/periodic reporting management.
This position is ideal for individuals looking to take ownership of global safety report submissions, lead major projects, and mentor junior team members while supporting regulatory compliance worldwide.
Key Responsibilities
As a Senior Safety Reporting Specialist, your responsibilities include:
- Receiving, preparing, and submitting expedited and periodic safety reports to global regulatory authorities.
- Ensuring 100% compliance with international regulatory timelines and local country-specific legislation.
- Leading large-scale safety reporting projects and ensuring high-quality, on-time execution.
- Providing feedback for the development and revision of program-level and department-level SOPs/process documents.
- Collaborating with cross-functional teams including clinical operations, regulatory, data management, and medical safety.
- Supporting new team members through mentoring and providing expert guidance.
- Generating safety reporting metrics and assisting in financial project components.
- Participating in regulatory intelligence initiatives and continuous process improvement.
Required Qualifications & Experience
Candidates must meet the following criteria:
- Bachelor’s degree (Life Sciences, Pharmacy, Nursing, or equivalent).
- Minimum 3+ years of relevant pharmacovigilance or safety reporting experience.
- Strong knowledge of medical terminology, global safety reporting requirements, and procedural documents.
- Excellent MS Office skills and understanding of safety databases.
- Ability to multitask, manage timelines, and maintain exceptional attention to detail.
- Strong interpersonal influence skills and experience interacting with senior-level stakeholders.
- Ability to work effectively in a collaborative remote environment.
- Demonstrated critical thinking, negotiation, and problem-solving abilities.
Why Apply for This Senior Safety Reporting Specialist Role?
- Fully remote work flexibility from anywhere in India
- Opportunity to work on global pharmacovigilance and regulatory compliance projects
- Career growth into leadership roles within drug safety
- Exposure to complex regulatory reporting environments and cross-functional teams
- Role suitable for professionals looking to advance their PV career beyond case processing
How to Apply
