Global Safety Coordinator

Location: Breda, Noord-Brabant  |  Sector: Pharmaceuticals  |  Start Date: 1/25/2024  |  Job ref: 52194

The Company
Our client is doing something amazing – they aim to help people receive better care by creating new and special treatments. They focus on patients who have very few or no options for treatment, and they make top-notch medicines for them.
Role description
We are looking for a committed Global Safety Coordinator to become part of our Local Pharmacovigilance team. The selected candidate will have a vital role in handling adverse events reported from homecare programs, ensuring prompt and precise entry of data into the Global Safety Database. The main duty includes communicating with Dutch Health Care Professionals (HCPs) through letters to collect additional information regarding adverse events in patients participating in Patient Support Programs (PSPs).
Responsibilities

-Process and input adverse events into the Global Safety Database with efficiency.
-Ensure timely submission of reportable adverse drug reactions and distribution of safety reports, adhering to both local regulations and Amgen procedures.
-Facilitate the exchange of adverse event information with service providers based on specific agreements.
-Work collaboratively with the Safety Manager and Senior Safety Associate to maintain local operating standards and ensure reporting compliance.
-Contribute to the resolution of local issues through Corrective and Preventive Actions (CAPAs) and related activities.
-Implement local quality assurance measures to ensure the safety function is inspection ready.

Requirements

-Minimum of an MBO+ or HBO degree.
-Possess a robust administrative background with expertise in Office applications.
-Ability to work in accordance with standardized English procedures.
-Fluency in Dutch and English to facilitate effective communication.
-A team player with computer literacy and proficiency in database usage.

Other Information
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About us

Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.