Soortgelijke vacatures
WE PUSH THE BOUNDARIES OF MEDICINE.
LEAPING FORWARD TO MAKE PEOPLE SMILE
Everything we do at KKI, is rooted in the idea of leaping forward to make people smile. We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis – our team is proud of all we deliver, but also humble in knowing how much more needs to be done. By listening to patient stories, we gain a better understanding of the obstacles patients and their families face – so we can work to better meet their unique needs. The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work. While the journey is not easy, it is one that is filled with purpose.
Job purpose:
A combined role for covering Pharmacovigilance (PV) and Regulatory Affairs (RA) for the BeNeLux countries. 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.
LEAPING FORWARD TO MAKE PEOPLE SMILE
Everything we do at KKI, is rooted in the idea of leaping forward to make people smile. We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis – our team is proud of all we deliver, but also humble in knowing how much more needs to be done. By listening to patient stories, we gain a better understanding of the obstacles patients and their families face – so we can work to better meet their unique needs. The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work. While the journey is not easy, it is one that is filled with purpose.
Job purpose:
A combined role for covering Pharmacovigilance (PV) and Regulatory Affairs (RA) for the BeNeLux countries. 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.
Your responsibilities
Pharmacovigilance:
- 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
- The primary point of contact for the oversight and management of Individual Case Safety Reports identified in the countries, including maintaining local tracking systems and reconciliation
- Oversight and management of any contractors or vendors employed to support PV
- Work closely with Global KK PV regarding any information requests or issues or responses relating to product safety locally aggregate reports
- Collaborate with local Medical Affairs and KK Global PV, to implement local Risk Minimisation commitments
- Collaborate with QA and KK PV Compliance in internal and external PV audits and authority inspections
- Ensure all appropriate local procedures and systems are in place for the local PV system
- Perform local PV training of all relevant personnel
- Ensure PV agreements are in place
- Ensure awareness of KK-sponsored digital media activity
- Collaborate with local Medical Affairs and Commercial personnel in the management of medical enquiries and quality complaints and awareness of any local Organised Data Collection programmes (ODCs)
- Compliance with relevant regulatory legislation and guidelines, and company procedures (Timely packaging component artwork review and approval, following KKI processes and systems, to ensure that all relevant local legislation is met, e.g. ‘blue box’ requirements; Local downstream communication of regulatory procedure outcomes on receipt of notification from HQ-RA)
- Ensure any local regulatory submissions and responses are prepared, peer-reviewed and submitted within agreed internal timelines and/or external deadlines, as necessary
- Provision of local regulatory advice and support to HQ Regulatory Affairs, cross-functional teams, affiliates and partners, as necessary
- Maintain electronic records for all submissions and communications with regulatory authorities, together with any supporting documentation
- Author, review and train relevant staff on Regulatory Standard Operation Procedures and Department Guidelines as required
- Act on new safety information received in an appropriate and timely manner
Your profile
- University degree in Pharmaceutical Sciences or equivalent
- Expert regulatory knowledge of European regulatory procedures and local procedures in the countries of responsibility
- Knowledge of regulatory compliance and change control
- Relevant experience of PV within the pharmaceutical industry
- Knowledge of relevant laws and regulations in the territories
- Knowledge of relevant therapeutic areas is an advantage
- Experience in translating corporate strategies into a local context, and a level of commercial awareness
- Fluent in Dutch and English, both verbal and written, preferably with proficiency in French
We offer
BENEFITS:
In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development. Plus:
In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development. Plus:
- Competitive salary
- Bonus
- Pension scheme
- Private medical insurance
