Job Description
Job Description:
- Review cases in the ICSR Submission workflow: Evaluate incoming safety reports to identify relevant information and ensure that all necessary data is available for reporting.
- Check if ICSRs meet reporting requirements to the Health Authority: Assess each case against established regulatory criteria to determine if it is reportable to health authorities, ensuring compliance.
- Perform local data entry as required: Input necessary information into the safety database accurately and promptly, ensuring that all case details are captured for effective tracking and reporting. Attach any necessary documents (literature articles) for reporting.
- Ensure cases are submitted within timelines to meet compliance: Monitor submission deadlines closely to guarantee that all reportable cases are submitted on time, thereby adhering to regulatory timelines
- Collaborate with internal teams regarding case status and submission issues: Communicate effectively with cross-functional teams, such as DDIT, to resolve any issues related to case processing and submission.
- Prepare reports for internal and external stakeholders as required: Generate comprehensive reports summarizing submission activities and case statuses for various stakeholders, ensuring transparency and effective communication within the organization
Strategic Impact:
Contributes to or even impacts the results of own team. Exchanges straightforward information, asks questions and checks for understanding.
Education:
Bachelor’s/Master's degree in Pharmacy
Strong experience in Pharmacovigilance
