Job Title: Senior Safety Reporting Specialist
Job ID: R-01337635
Employment Type: Full-Time
Work Mode: Fully Remote
Category: Clinical Research / Pharmacovigilance / Safety Reporting
Location: Remote – India
Work Schedule: Standard (Monday to Friday)
Experience Required: 3–6 Years
Job Overview
We are hiring a Senior Safety Reporting Specialist to lead and manage global safety reporting activities for clinical research projects. This role is critical in ensuring regulatory compliance, data quality, and timely submission of expedited and periodic safety reports across multiple regions.
As part of a leading global Contract Research Organization (CRO) supporting the PPD® clinical research portfolio, you will play a senior, hands-on role in project leadership, process improvement, and mentoring junior team members while serving as a key point of contact for safety reporting initiatives.
About the Organization
Our Clinical Research Services team is dedicated to advancing therapies that address some of the world’s most complex health challenges. By combining scientific expertise, regulatory knowledge, and operational excellence, we support global drug development programs and help bring innovative treatments to patients worldwide.
Role Summary
The Senior Safety Reporting Specialist is responsible for the end-to-end management of safety reports, including receipt, preparation, submission, and tracking. The role requires proactive issue identification, leadership in large-scale programs, and close collaboration with cross-functional stakeholders to ensure compliance with global pharmacovigilance regulations and timelines.
Key Responsibilities
Safety Reporting & Compliance
Receive, prepare, submit, and track expedited and periodic safety reports in compliance with global regulatory timelines and country-specific legislation.
Monitor reporting activities continuously and proactively identify quality or timeline risks, escalating issues as needed.
Ensure adherence to approved procedural documents, SOPs, and global safety reporting requirements.
Project & Program Leadership
Lead large-scale safety reporting projects and programs, ensuring consistent execution across teams.
Serve as a subject matter expert for safety reporting activities and regulatory expectations.
Produce safety metrics and support select financial and project tracking activities.
Process Improvement & Regulatory Support
Contribute to the development, review, and update of program-level and departmental procedures.
Support regulatory intelligence initiatives and continuous improvement efforts within safety operations.
Actively share ideas and participate in the implementation of process enhancements.
Cross-Functional Collaboration
Liaise with internal departments and external stakeholders to coordinate safety reporting deliverables.
Attend and contribute to cross-functional and project meetings as required.
Represent the department as a primary contact on assigned projects.
Mentorship & Team Development
Provide guidance, feedback, and hands-on support to junior team members.
Mentor new hires and support onboarding and skill development within the safety reporting team.
Professional Level
This is a career-level, fully qualified senior role requiring independent judgment, creative problem-solving, and deep functional expertise in pharmacovigilance and safety reporting.
Education & Experience
Education:
Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related discipline.
Relevant academic or vocational qualifications in pharmacovigilance or clinical research are preferred.
Experience:
Minimum 3+ years of hands-on experience in safety reporting, pharmacovigilance, or clinical research safety operations.
Equivalent combinations of education, training, and directly related experience may be considered.
Required Knowledge, Skills & Abilities
Strong expertise in medical terminology and global safety reporting standards.
In-depth knowledge of SOPs, procedural documents, and regulatory requirements (e.g., ICH, CIOMS, local regulations).
Excellent proficiency in Microsoft Office and strong understanding of safety databases and reporting systems.
Proven ability to manage multiple priorities with strong time management skills.
Exceptional attention to detail and quality focus.
Ability to influence and collaborate effectively across all organizational levels.
Strong critical thinking, problem-solving, negotiation, and decision-making abilities.
Demonstrated capability to mentor and support junior colleagues in safety reporting activities.
Why Join This Role
Work remotely on global clinical research programs with high regulatory impact.
Take ownership of complex safety reporting projects and influence operational excellence.
Grow your leadership profile within pharmacovigilance and clinical safety operations.
Be part of a collaborative, science-driven environment committed to patient safety and compliance.
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