Title: Senior Safety Reporting Specialist
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research – Pharmacovigilance / Safety Reporting
Company Overview:
Join Thermo Fisher Scientific, a global leader in clinical research services, committed to advancing drug development and bringing innovative therapies to market. Our Clinical Research team, powering the PPD® portfolio, combines scientific expertise and technology to support pharmaceutical clients worldwide.
Role Overview:
The Senior Safety Reporting Specialist is responsible for the receipt, preparation, submission, and tracking of expedited and periodic safety reports. The role ensures full compliance with global regulatory timelines and legislation. The specialist leads projects, mentors team members, and provides input into process improvements and regulatory intelligence initiatives, contributing to high-quality pharmacovigilance operations.
Key Responsibilities:
Safety Reporting & Compliance
Receive, review, and submit safety reports for applicable projects, ensuring accuracy and regulatory compliance.
Monitor timelines and escalate potential quality or deadline issues proactively.
Lead large-scale safety reporting projects, ensuring adherence to global regulatory standards and internal processes.
Process Improvement & Mentorship
Provide guidance and support to team members, including mentoring new staff.
Contribute to the development, review, and implementation of procedural documents and departmental best practices.
Offer input on safety reporting process enhancements and regulatory updates.
Collaboration & Communication
Liaise with internal and external stakeholders regarding safety reporting activities.
Attend project meetings and provide updates on reporting metrics and project progress.
Represent the department as a primary contact on significant safety reporting matters.
Project Metrics & Reporting
Track and report key metrics for assigned projects.
Provide support for financial tracking, project reporting, and audit readiness activities.
Qualifications & Experience:
Bachelor’s degree in life sciences, pharmacy, or a related field.
3+ years of experience in pharmacovigilance or safety reporting in the pharmaceutical or CRO environment.
Strong knowledge of medical terminology and safety reporting requirements.
Familiarity with regulatory guidelines for safety reporting (global and country-specific).
Skills & Competencies:
Excellent attention to detail and ability to manage multiple tasks simultaneously.
Strong time management, critical thinking, and problem-solving skills.
Proficiency in Microsoft Office and understanding of safety databases.
Effective collaboration and communication skills, with the ability to influence at all organizational levels.
Demonstrated initiative, negotiation skills, and ability to support junior colleagues in safety reporting activities.
Why Join Us:
Contribute to global pharmacovigilance efforts and enhance patient safety.
Work remotely with cross-functional teams in a supportive, collaborative environment.
Grow your career within a leading global clinical research organization.
Equal Opportunity Employer:
Thermo Fisher Scientific is committed to diversity, equity, and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or legally protected status.
Apply Today: Take the next step in your pharmacovigilance career and join a team dedicated to delivering safe and effective therapies worldwide.
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bangor | Brewer |New Jersey :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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