Thermo Fisher Scientific is hiring for the position of Safety Reporting Specialist for its Remote India team. This is a full-time, fully remote opportunity for candidates with at least 2 years of relevant experience in safety reporting and pharmacovigilance-related activities.
The selected candidate will manage and coordinate regulatory and safety report production, ensure accurate documentation of adverse events, and support compliance with global pharmacovigilance requirements.
Candidates with knowledge of global safety reporting regulations, medical terminology, safety databases, and regulatory documentation can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | Thermo Fisher Scientific |
| Job Role | Safety Reporting Specialist |
| Job ID | R-01371264 |
| Job Location | Remote, India |
| Work Mode | Fully Remote |
| Employment Type | Full-Time |
| Experience | 2+ Years |
| Qualification | Bachelor’s Degree or Equivalent |
| Work Schedule | Monday–Friday |
| Department | Safety Reporting / Pharmacovigilance |
Position: Safety Reporting Specialist
The Safety Reporting Specialist will coordinate the preparation and submission of safety reports while ensuring compliance with regulatory timelines and country-specific legislation.
The role also involves maintaining safety reporting systems, preparing quality metrics, supporting audits, coordinating with internal departments, and contributing to process improvement initiatives.
Key Responsibilities
- Receive, prepare, and submit safety reports to applicable parties.
- Ensure safety reports are submitted within regulatory timelines and in accordance with country legislation.
- Escalate reporting issues to the lead or line manager.
- Assist in preparing metrics and identifying quality or timeline-related issues.
- Participate in project teams and lead small to moderate projects when required.
- Provide training and support to other team members.
- Maintain safety reporting systems, documentation, and filing records.
- Coordinate with different departments regarding safety reporting activities and client account setup.
- Participate in audits and perform testing activities when required.
- Contribute suggestions and participate in process improvement initiatives.
Eligibility and Qualifications
Candidates applying for the Safety Reporting Specialist position should meet the following requirements:
- Bachelor’s Degree or equivalent.
- Relevant formal academic or vocational qualification.
- Previous relevant experience comparable to at least 2 years.
- Candidates with an appropriate combination of education, training, and directly related experience may also be considered.
Required Skills and Knowledge
- Strong knowledge of medical terminology.
- Good written and verbal communication skills.
- Proficiency in Microsoft Word and Excel.
- Understanding of safety database functionality.
- Knowledge of procedural documents and global safety reporting requirements.
- Familiarity with FDA regulations and guidelines.
- Strong attention to detail and accuracy.
- Ability to manage multiple tasks while maintaining quality.
- Ability to handle sensitive information and data appropriately.
- Strong critical-thinking and problem-solving skills.
- Ability to communicate effectively with different organizational teams.
Working Conditions and Requirements
- Work schedule: Monday to Friday.
- Ability to work in an office, laboratory, or clinical environment as applicable to assigned activities.
- Ability to remain in an upright or stationary position for 6–8 hours per day.
- Ability to perform repetitive computer-related hand movements.
- Ability to manage multiple tasks and work under changing conditions.
- Ability to lift and carry objects weighing up to 15–20 lbs when required.
- Regular and consistent attendance.
