Safety Specialist, Belgium - Utsjoki

Job summary

As a Safety Specialist at Thermo Fisher Scientific, you will be responsible for performing day-to-day pharmacovigilance activities within a highly regulated environment. This includes monitoring for, collecting, translating, disseminating and tracking of safety information, as well as serving as a regulatory authority contact point.

Responsibilities

• Supporting activities such as data entry, coding and assessment of adverse events, follow-up, tracking of reports, and regulatory reporting activities.
• Collaborating with various parties across the world such as project team members, client contacts, reporters, and third-party vendors.
• Assisting in the preparation of departmental and project-specific procedures and processes; preparing for and attending meetings, audits and regulatory authority inspections.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
• Reviews cases and other documents for quality, consistency, and accuracy.
• Prepares and maintains regulatory safety reports.

Työn kuvaus