Senior Scientific Advisor Nordics (M/F)
MAIN PURPOSE:As the Senior Scientific Advisor for the Nordics, you will be responsible for Secure quality of Pharmacovigilance, Code compliance, Medical Information, Medical training and Good Clinical Practice (GCP) across the region.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
With regards to Medical Information
- Maintenance of Medical Information including; standard letters; FAQs; studies and monthly reconciliation.
- First contact person for all medical questions according to (product description and approval) SPC´s and standard response documents for DK, SE, NO, FI, ICE – or after consulting the Medical Director.
With regards to Clinical Trials
- Assist the Medical Director in administrating Norgine sponsored clinical trials and studies.
- ensure that Norgine sponsored clinical trails are GCP (Good Clinical practice) compliant.
- Office and field support to the Customer Facing Medical staff and Investigator Initiated studies activities.
With regards to Training
- Development and production of manuals, presentations and other applicable training materials in collaboration with the Medical Director.
- Training of commercial staff: Medical training, Pharmacovigilance and Code of practice.
With regards to Pharmacovigilance (PV)
- Collect, translate and report all Adverse Events (AEs) promptly and accurately according to the Norgine PV model.
- Ensure that AEs are managed in compliance with local regulations and Norgine SOPs (Standard Operating Procedures)
- In collaboration with the Medical Director, train the Nordic employees on Pharmacovigilance and maintain records of the training.
- Responsible for filing, including local reporting systems
With regards to Code of Practice
- Ensure that all activities are compliant with applicable Codes of Practice relating to the promotion of medicines and devices
- Assist the Medical Director with local processes related to Code of Practice compliance.
- Act as Deputy Approver (Signatory) on behalf of the Medical Director for material in Zinc (approval system)
Budget tracking, handling of invoices in collaboration with the Medical Director.
- A relevant scientific/medical master degree
- Ideally a first experience with a Pharmaceutical company as a Scientific Advisor
- Experience in interpreting and presenting clinical data
- Excellent verbal and written communication skills in English and at least one Nordic languages. Finnish in addition would also be an advantage.
- Experience with training of internal and external personnel
- Support for the MSL team
- Up to date knowledge in local legislation guidelines (DK, N, S, FI, Iceland) within medical devices, medical products, GVP, GCP and/or Code of Practice.
- Significant experience with copy approval is highly desirable
- Capacity to work autonomously, to prioritise but also to communicate with the wider team and stakeholders
- Excellent understanding of Microsoft Office (Word, Excel, PowerPoint)
- Contribute effectively in the team, respond positively to requests, engage in team work activities and objectives