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Safety Scientist- Real World Evidence RWE - Thermo Fisher Scientific
Software Engineer
Safety Scientist III focused on Real World Evidence in EMEA, driving signal detection, product safety analysis, and regulatory compliance across global clinical data sets.
About the role
Key Responsibilities
- Lead signal detection and product safety investigations using real‑world data across EMEA markets.
- Design and execute safety data analyses, integrating clinical trial and post‑marketing information.
- Prepare and submit safety reports to regulatory authorities, ensuring timely and compliant communication.
- Collaborate with cross‑functional teams (clinical, regulatory, medical affairs) to interpret safety signals and recommend risk mitigation strategies.
- Maintain and enhance safety databases, ensuring data integrity and adherence to industry standards.
Requirements
- Minimum 5 years’ experience in pharmacovigilance or safety science within the pharmaceutical or biotech sector.
- Strong knowledge of EMEA regulatory requirements and safety reporting frameworks.
- Proficiency in data analysis tools (e.g., SAS, R, or SQL) and safety database systems.
- Excellent communication skills, with the ability to present complex safety findings to diverse stakeholders.
- Demonstrated ability to work independently and manage multiple safety projects simultaneously.