Pharmacovigilance and Regulatory Affairs Manager BeNeLux
- Amsterdam
A combined role for covering Pharmacovigilance (PV) and Regulatory Affairs (RA) for the BeNeLux countries. * Provision of local regulatory advice and support to HQ Regulatory Affairs, cross-functional teams, affiliates and partners, as necessary - Responsible for the management and oversight of the pharmacovigilance system and activities for the company. Post-licensing regulatory activities associated with ensuring that all Kyowa Kirin International's marketed products in the BeNeLux countries are in compliance with applicable legislation and business requirements. * The local registered person for the Netherlands, and local persons are registered for Belgium and Luxembourg; ensure the regular monitoring of the regulatory authority websites * Collaborate with local Medical Affairs and KK Global PV, to implement local Risk Minimisation commitments
A combined role for covering Pharmacovigilance (PV) and Regulatory Affairs (RA) for the BeNeLux countries. * Provision of local regulatory advice and support to HQ Regulatory Affairs, cross-functional teams, affiliates and partners, as necessary - Responsible for the management and oversight of the pharmacovigilance system and activities for the company. Post-licensing regulatory activities associated with ensuring that all Kyowa Kirin International's marketed products in the BeNeLux countries are in compliance with applicable legislation and business requirements. * The local registered person for the Netherlands, and local persons are registered for Belgium and Luxembourg; ensure the regular monitoring of the regulatory authority websites * Collaborate with local Medical Affairs and KK Global PV, to implement local Risk Minimisation commitments
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