We are seeking a meticulous and proactive Associate Global Safety Officer to join our biotech clients' Local Pharmacovigilance (Patient Safety) team in Breda. The role involves managing and resolving pharmacovigilance tasks related to Patient Support Programs (PSPs), clinical trials, and spontaneous reports. You will play a vital part in ensuring patient safety by facilitating the exchange of information about adverse events between healthcare professionals (HCPs), patients, and internal systems.
Key Responsibilities:
- Timely and accurate processing of adverse events reported to the affiliate from various sources (letters, emails, or phone).
- Enable entry of all adverse events into the Global Safety Database.
- Send out letters to Dutch HCPs to request additional information on adverse events for patients enrolled in PSPs.
- Process follow-up letters from HCPs regarding adverse events.
- Ensure timely submission of reportable adverse drug reactions and distribution of periodic safety reports or urgent safety communications in compliance with local regulations and Amgen procedures.
- Work with the Safety Manager and Senior Safety Associate to maintain operational performance and reporting compliance.
- Facilitate the exchange of adverse event information with functional service providers in accordance with agreements or procedures.
- Participate in resolving local issues, including Corrective and Preventive Actions (CAPAs).
- Ensure inspection readiness of the local safety function through robust quality assurance measures.
- Distribute additional risk minimization measures (aRMMs).
- Support the processing and documentation of received follow-up letters related to aRMMs.
Qualifications & Requirements:
- Education: MBO+ or HBO degree.
- Strong administrative background with proficiency in Microsoft Office.
- Experience working with standardized procedures, preferably in English.
- Detail-oriented with excellent communication and team collaboration skills.
- Knowledge of databases and computer systems.
- Proactive and customer-oriented approach.
- Ability to seek guidance in unfamiliar situations.
Practicalities:
Languages: Fluency in Dutch and English (written and spoken).
Duration: 6 months contract with extension possibility
Location: Breda, Netherlands
Set up: 24h per week (flexible)