Safety Reporting Specialist

Thermo Fisher Scientific, a global leader in serving science, operates across life‑sciences research, diagnostics, and clinical services. Through its PPD® division, the company runs one of the world’s largest contract research organizations, helping pharmaceutical and biotech firms bring life‑saving medicines to market. With a workforce of over 100,000 professionals, Thermo Fisher fosters a culture of scientific rigor, innovation, and collaboration, offering employees exposure to cutting‑edge technologies and a truly global footprint.

The organization’s commitment to diversity, inclusion, and employee well‑being makes it an attractive destination for fresh talent seeking a purpose‑driven career.

The Safety Reporting Specialist role sits within the Clinical Research Services team, focusing on pharmacovigilance and safety data management for clinical trials. The specialist ensures that all adverse events and safety information are captured, assessed, and reported in compliance with global regulatory requirements. This position is ideal for recent graduates with a strong scientific background and an eye for detail, who wish to contribute directly to patient safety and drug development.

Key Responsibilities

• Collect, review, and assess adverse event data from clinical trial sites.
• Prepare and submit safety reports (e.g., SUSAR, DSUR) to regulatory authorities in accordance with local and international guidelines.
• Maintain accurate safety databases and ensure data integrity.
• Liaise with clinical teams, investigators, and CROs to obtain missing safety information.
• Conduct signal detection and trend analysis to identify potential safety concerns.
• Support the preparation of safety narratives for clinical study reports.
• Ensure compliance with ICH E2A/E2B/E2F guidelines and internal SOPs.
• Participate in internal audits and regulatory inspections related to safety reporting.
• Provide training and guidance to junior staff on safety reporting processes.
• Contribute to continuous improvement initiatives within the pharmacovigilance function.

Tech Stack & Tools: Microsoft Office Suite, safety database systems (e.g., Argus Safety, Oracle Argus), MedDRA coding, clinical trial management systems (CTMS), and basic data analysis tools.

Growth Path: Starting as a Safety Reporting Specialist, high performers can advance to Senior Specialist, Pharmacovigilance Lead, or Manager roles, eventually moving into global safety strategy or regulatory affairs positions. The role offers exposure to cross‑functional teams, enabling a broad skill set that is valuable across the pharmaceutical industry.

Why Join Thermo Fisher? Employees benefit from a robust learning environment, mentorship from seasoned scientists, and the chance to work on impactful projects that directly affect patient health. The company’s global presence provides opportunities for international exposure, while its emphasis on work‑life balance and employee wellness ensures a supportive workplace.