To reinforce the Vigilance department, infarAMA is currently looking for a
infarAMA is an independent consultancy company providing high standard professional expertise in global regulatory affairs, quality assurance, vigilance and translation services to the health care industry within Benelux. infarAMA is headquartered in Strombeek-Bever and has a brand-new subsidiary in Aarschot.
- Comply with vigilance best practices and provide input to contribute to the evolution of the departments activity
- Stay ahead of changes in regulatory requirements in relation to safety (pharmacovigilance and materiovigilance)
- Ensure that all safety information is efficiently handled and submitted within the legally defined timelines according to standard operating procedures and working instructions
- 24/7-call handling and administration
- Case processing
- Literature screening
- Assist, review or draft aggregate reports
- Participate in self-inspections and audits
- Develop and deliver training regarding vigilance procedures to staff and contractors
- Interact with the Regulatory Affairs & Quality Assurance department
- Scientific degree (pharmacist, biomedical science or equivalent by experience)
- 2 years of relevant experience in a similar function in the pharmaceutical industry (irrelevant for Junior Safety Officer positions)
- Fluent in English, Dutch and French with excellent oral and written communication skills
- Strong knowledge of current software
- Meticulous, methodological, enthusiastic, flexible and reliable
- Able to work both independently and in teams
- A varied job consisting in challenging multi-disciplinary tasks in a dynamic and growing environment
- Competitive benefits and compensation packages
- Workplace in Aarschot or in Strombeek-Bever
Interested? Send your resume and application letter to firstname.lastname@example.org.
For more information, feel free to contact us.