Thermo Fisher Scientific is a global leader in scientific research and healthcare, dedicated to enabling customers to make the world healthier, cleaner, and safer. With clinical trials conducted in over 100 countries, Thermo Fisher Scientific plays a pivotal role in advancing drug development through cutting-edge laboratory, digital, and decentralized clinical trial services.
The company fosters a collaborative work environment where employees are empowered to grow professionally while contributing to life-changing therapies. Their Pharmacovigilance team ensures drug safety across all phases of clinical trials, maintaining compliance with global regulatory standards.
Job Description: Senior Safety Reporting Specialist
As a Senior Safety Reporting Specialist, you will manage the receipt, submission, and tracking of expedited and periodic safety reports for clinical trials. This role ensures compliance with regulatory timelines and supports pharmacovigilance activities across multiple projects.
Key Responsibilities:
- Safety Reporting: Receive, prepare, and submit safety reports to regulatory bodies and clients within required timelines.
- Compliance & Quality Control: Ensure adherence to FDA regulations, ICH guidelines, and country-specific legislation.
- Project Support: Assist in generating safety metrics, identifying quality issues, and escalating concerns to management.
- Process Improvement: Participate in audits, process enhancements, and training initiatives.
- Cross-functional Collaboration: Work with internal teams and clients to set up safety reporting systems and accounts.
Qualifications & Skills:
- Education: Bachelor’s degree or equivalent in life sciences or related field.
- Experience: 2+ years in pharmacovigilance, drug safety, or regulatory reporting.
- Technical Skills: Proficiency in Microsoft Office, safety databases, and medical terminology.
- Soft Skills: Strong attention to detail, problem-solving abilities, and effective communication.
- Regulatory Knowledge: Familiarity with global safety reporting requirements (FDA, EMA, etc.).
Work Environment:
- Fully Remote (India) – Flexible work setup.
- Collaborative Culture – Engage with global teams and contribute to impactful projects.
- Professional Growth – Opportunities for training and career advancement.