Ihr Profil
CSL Vifor, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, is experiencing rapid growth due to the realization, continued expansion, and optimization of its pipeline and portfolio strategy.
We are currently looking for a Medical Affairs Officer (Quality Assurance, Regulatory Affairs, Pharmacovigilance) to be in charge of the pharmaceutical affairs. The role is based at our office in Solna and will report to the Head of Medical Nordics.
Your tasks and responsibilities will also include, but are not limited to, the following:
General:
- Communicate with the local authorities regarding wholesale, pharmacovigilance and regulatory issues in the Nordic countries
- Keep contact information to key staff for urgent issues updated
- Monitoring and communication of updates local regulations and guidelines in regulatory, pharmacovigilance and wholesale
Quality:
- Quality manager tasks
- Evaluation, qualification and supervision of GDP/GMP/GVP-relevant external service providers/distributors
- Perform quality controls and reconciliation to ensure compliance to timelines and quality standards
- Initiate, manage and document deviations, corrective actions and preventive actions (CAPAs) when a GDP or GVP relevant issue is discovered
- Administration of change control processes
- Call for, lead and document annual Management review meetings
- Administration of trainings and documentation in LMS as Key User
- Perform self-inspections in GxP areas
Wholesale:
- Handle complaints and recalls in the Nordic countries
- Ensure correct documentation and storage of technical samples
- Notification of essential GDP relevant changes to the Nordic Competent Authorities
- Internal preparation and lead during GDP audits/inspections of Vifor Pharma Nordiska
- Training of internal and external personnel with regard to GDP aspects
Pharmacovigilance:
- Handling of reports with relevant safety information within the Nordic countries in accordance with current regulations and contractual arrangements
- Perform literature searches in local scientific medical literature
- Forward urgent safety restrictions and other emerging safety issues to GDS/QPPV
- Monthly reporting to the EU-QPPV
- Internal preparation and lead during GVP audits/inspections of Vifor Pharma Nordiska
- Training of internal and external personnel with regard to Pharmacovigilance
Regulatory:
- Keep local product databases, both internal and external, up to date to ensure use of latest approved product information
- Control of abbreviated product information (AbPI) in promotional material
- Control and print approval of mock-ups/regulatory artworks
- Quality Check and linguistic review of regulatory documents (e.g. Product information, CCDS)
- Efficient internal communication of regulatory information (e.g. product information updates, launch/withdrawal of SKUs on the market
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
Minimum Requirements
- Exam within Medicine, Biology or Pharmacy
- Minimum 5 year of experience in pharmaceutical industry
- Having good knowledge of applicable regulations within wholesale and pharmacovigilance
- Experience in pharmacovigilance in the Nordic countries
- Competence for approval as RP wholesale by the Swedish authority
- Experience of regulatory affairs on the Nordic markets
- Good MS Office skills
- Professional level in English, both in oral and in written communications
- Knowledge of the pharmaceutical industries ethical rules (IMA training)
Preferred Requirements
- Experience of Nordic product databases (e.g. LiiV, Felleskatalogen, DKMAnet, Pharmaca Fennica)
- Experience in Medical Affairs in the pharmaceutical industry
- Demonstrated ability to accurately and effectively evaluate medical scientific literature
- Understanding of medical aspects of therapeutic area along with willingness to develop in-depth expertise
- Experience of GDP and GVP audits and inspections