Kyowa Hakko Kirin is a Japanese research-based life sciences company with special strengths in biotechnology. We are opening up the path toward the development of new biologics, and developing new medicines to meet medical needs that are currently not being satisfied by existing pharmaceuticals. We are approximately 8000 employees world-wide.
In the Nordic & Baltic region, we are close to 30 employees and work within a fast-moving and dynamic environment. Currently, we are looking to strengthen our organisation with a
Nordic Regulatory Affairs and Pharmacovigilance Manager
This is a combined role for covering Regulatory Affairs and PV matters for the Nordic/Baltic countries. You will be responsible for regulatory activities associated with worldwide development including development of regulatory strategy, due diligence, gaining regulatory approvals for clinical trial and marketing applications and maintenance of these authorisations where appropriate. You will also be responsible for the pharmacovigilance system and activities in the Nordic/Baltic countries within the company.
• Regulatory approvals for clinical trial and marketing applications
• Maintenance of the authorisations
• Approval of product artwork (SPC, PIL, labels)
• Due diligence when applicable
• Management of compliance with relevant regulatory legislation and guidelines.
• Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice.
• Ensuring effective communications & collaboration between the Development Group and regulatory authorities, licensing partners and country contacts.
• Ensuring that new safety information received is acted upon, as appropriate, in a timely manner.
• Responsible for collection and tracking of all initial receipt of reports of Adverse Drug Reactions (“ADRs”) within the Nordic/Baltic region.
• Ensure that a report of each case is prepared on a CIOMS form and forwarded to the Global Drug Safety department (GDS) within 48 hours from initial date of receipt (48-96 hours for cases received on weekend or national public day).
• Maintain log of all cases sent to GDS.
• Ensure that case reports are translated to English when needed.
• Monitor and document activities relating to the maintenance of the awareness for local medical journals.
• Ensure that relevant Adverse Event portals for the Competent Authorities in the Nordic region are monitored regularly.
• Ensure that follow-up information is collected for cases if necessary and that all attempts to receive follow-up information are recorded.
• Responsible for the training of the Nordic/Baltic Kyowa Kirin team in Drug Safety reporting.
• University degree in Pharmaceutical Sciences or equivalent
• Experience from PV within the pharmaceutical industry is an advantage (from at least one Nordic country)
• At least five years experience from Regulatory Affairs within the pharmaceutical industry (from at least one Nordic country)
• Knowledge of relevant laws and regulations
• Knowledge of relevant therapeutic areas is a merit
• Previous experience from working on a Nordic level is an advantage
• Be recognized as a well-respected RA/PV manager with a high level of integrity.
• Experience in translating corporate strategies into a local context.
• Fluent in English, both verbal and written, as well as proficiency in the Scandinavian languages
• Ability to work in a team
• Commercially driven
Please send your application including CV to email@example.com as soon as possible!
How your information will be used
In order to progress your application, for administrative purposes we will record, keep, and hold the personal data which you have provided in this application form stored in our Human Resources files. Your data will not be transferred to any third parties outside of our group companies. Your personal data may be stored outside of the EEA for the purposes of processing your application, for example because our applications system, Greenhouse, is hosted in the USA. If we do store your personal information outside of the EEA, we will do so using one of the adequate safeguards permitted by regulators for transfers of personal data outside of the EEA, for example we may use the appropriate safeguard of the model contractual clauses approved by regulators.
If your application is successful, we will hold this data as part of your employee record and you will be provided with a copy of our Employee Privacy Notice. In the event that your application is unsuccessful, we will hold the application form and the data contained in it for six months in case of a future vacancy which we may invite you to apply for and for the establishment, exercise or defence of any legal claims. After six months we will delete you application form, the data contained within it and any other personal data that you may have provided to us.
Please see our Privacy Notice for further information on how we process your personal data, including how we keep your personal data secure and your rights; http://www.international.kyowa-kirin.com/se/extern-personuppgiftspolicy.html. If you have any questions about our use of your data, please contact us by email at KKIDPOoffice@kyowakirin.com.