Key Duties
Responsibilities:
Implement Pharmacovigilance (PV) policies in alignment with corporate strategy, ensuring local compliance with regulations and quality local scientific and regulatory intelligence in PV, evaluating and mitigating risks associated with clinical product as the primary contact for regulatory affairs (RA), overseeing submissions, variations, and renewals for marketing product quality complaints and ensure compliance with good practices (GMP, GDP, GCP).Review and approve promotional materials, provide scientific support to sales and marketing teams, and deliver product-related scientific training.Provide medical information to customers, participate in medical information networks, and engage with key opinion leaders.Oversee clinical studies, liaising with authorities and ethical committees, and managing investigator-initiated studies.Fulfill specific responsibilities for the BeNeLux region, including serving as the local Qualified Person in Pharmacovigilance (QPPV) and Responsible for Information and Publicity (RIP) in Belgium.
Package and Benefits
annual base salary up to €100,000.- DOE10%% bonuscompany carbenefits
Key Skills, Qualifications and Client Requirements
Pharmacist or medical doctor with extensive experience and qualifications to oversee PV and RA activities, along with proficiency in administrative tasks related to clinical knowledge in contrast media and medical devices is advantageous.Essential to hold a relevant scientific degree (MD, PhD, or PharmaD).Minimum of 5 years of experience in the biotechnology/pharmaceutical field.Proficient in English, Dutch, and French, both spoken and experience as a medical affairs manager is essential.Demonstrated success in building relationships within the industry.Ability to effectively present complex scientific data.Previous exposure to complex matrix organizations or virtual team environments is multitasking, project management, and execution abilities.Excellent interpersonal skills, including communication, presentation, persuasion, and influence.Effective organizational skills, demonstrating efficiency, punctuality, and collaboration in team settings.Proficiency in computer skills, including MS Office.