Senior Safety Reporting Specialist – Pharmacovigilance
Location: Fully Remote – India
Job Type: Full-Time
Job ID: R-01337635
Category: Clinical Research / Pharmacovigilance
Work Schedule: Standard (Monday to Friday)
About the Organization
Our Clinical Research Services team operates at the forefront of global drug development, supporting the timely delivery of innovative therapies that address critical and complex health challenges. As part of a leading global Contract Research Organization (CRO) and the PPD® clinical research portfolio, our professionals bring deep scientific, regulatory, and operational expertise to pharmacovigilance and safety reporting activities across global clinical programs.
Role Overview
The Senior Safety Reporting Specialist is responsible for the end-to-end management of expedited and periodic safety reports across assigned clinical research projects. This role requires strong expertise in global safety reporting regulations, proactive issue management, and the ability to lead safety reporting activities for complex programs. The position also involves mentoring team members, contributing to procedural improvements, and supporting regulatory intelligence initiatives to ensure compliance and operational excellence.
Key Responsibilities
Receive, prepare, submit, and track expedited and periodic safety reports in compliance with global regulatory timelines and country-specific legislation.
Ensure continuous oversight of safety reporting activities to maintain compliance with regulatory requirements and internal procedures.
Lead large-scale safety reporting projects and programs, ensuring consistent adherence to agreed processes and timelines.
Proactively identify quality or timeline risks and escalate issues to management with recommended solutions.
Serve as a primary safety reporting contact for assigned projects, coordinating with internal and external stakeholders.
Provide guidance, feedback, and mentorship to junior team members and new hires.
Contribute to the development, review, and update of safety reporting procedures and departmental documentation.
Participate in regulatory intelligence activities and continuous improvement initiatives related to pharmacovigilance.
Produce safety metrics and support project-level tracking, including limited financial or resource-related inputs.
Represent the safety reporting function in cross-functional meetings and project discussions as required.
Experience and Qualifications Required
Bachelor’s degree or equivalent formal academic or vocational qualification in life sciences or a related discipline.
Minimum 3+ years of hands-on experience in safety reporting, pharmacovigilance, or clinical research safety operations.
Strong working knowledge of global safety reporting regulations, including expedited and periodic reporting requirements.
Demonstrated experience preparing and submitting safety reports to regulatory authorities and other applicable parties.
Excellent understanding of medical terminology and safety data concepts.
Proficiency in Microsoft Office applications and working knowledge of safety databases and reporting systems.
Proven ability to manage multiple priorities, meet regulatory timelines, and maintain high attention to detail.
Strong analytical, critical thinking, and problem-solving skills.
Ability to influence and collaborate effectively with stakeholders at all organizational levels.
Demonstrated leadership capability, with experience mentoring and supporting junior colleagues.
Strong communication, negotiation, and interpersonal skills, with a collaborative and proactive approach.
Why Join This Opportunity
Fully remote role offering flexibility and work-life balance within a global pharmacovigilance environment.
Opportunity to lead safety reporting activities on complex, multinational clinical programs.
Collaborative, quality-driven culture that values expertise, accountability, and continuous improvement.
Long-term career development opportunities within clinical research and drug safety.
How to Apply
Qualified professionals with pharmacovigilance and safety reporting experience are encouraged to apply through the official careers portal. Applications are reviewed on a rolling basis.
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