- Collection, documentation and any further local processing of adverse event and pregnancy reports
- Collection, review and evaluation of safety-related scientific literature and other sources of information
- Signal detection activities for Fumaderm
- Support authoring RMP, PSUR, DSUR and any other documents for Fumaderm
- Co-operation with GSRS and other international Biogen organizations and local departments
- Departmental internal training of (new) safety associates
- Ensuring Drug Safety related internal processes and documents are in compliance with company and regulatory obligations and standards
- German Contact Point for BfArM and PEI regarding Drug Safety topics
- Coordination and organization of departmental functions
- Support and consulting of subordinate employees
- Targeted management of subordinate employees
- Monitoring of objectives and evaluation of results
- Cooperation with Heads of Regulatory Affairs, Medical Teams and other Departments
- Cooperation with regional and global Biogen SABR, Regulatory and Medical Organizations
- Coordination with QA/Compliance department in safety relevant issues
- Set up and manage a pharmacovigilance system
- Collect and evaluate notifications on medicinal product risks that have become known and co-ordinate the necessary measures
- Responsible for meeting to obligations to notify in so far as they concern medicinal product risks
- Ensure that additional information for the evaluation of the risk-benefit profile of a medicinal product, including his/her own evaluations, are sent immediately and in full, if requested by the competent higher federal authority
- Support processing of and following up on product complaints
- Support other departments in drug safety issues, including generation of SmPC and PIL and other regulatory documents
- Review of promotional material as needed
- Preparation of safety relevant information for internal materials
- Transfer of drug safety-related knowledge within the department and across company departments and divisions
- Attend national/international pharmacovigilance and medical congresses, as needed
- University degree in Scientific Studies (human or veterinary medicine, pharmacy, biology or equivalent) with proven experience within PV
- At least 10 years processional experience, of which at least 5 years working experience in Drug Safety or relevant clinical/pharmaceutical experience
- Knowledge of local German Pharmacovigilance regulations
- At least 3 years of People Management experience
- Ability to set priorities and work independently
- Organized and structured working method
- Fluency in German and English
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Associate Director, DACH Regional Drug Safety Lead - Munich, Deutschland - Biogen
Beschreibung
Job Description
For our office in Munich (in a hybrid working model) we are recruiting for a
Associate Director, DACH Regional Drug Safety Lead (f/m/d)
The Associate Director, DACH Regional Drug Safety Lead (f/m/d) is responsible for leading the Drug Safety departments for the DACH region (Germany, Austria, Switzerland), including line management of the local team, implementing and overseeing tasks defined in Biogen's global and local Policies and SOPs. They will ensure compliance with regulatory and company obligations and standards related to pharmacovigilance, consult on pharmacovigilance issues and oversee and support processing of adverse events and product complaints.
Accountabilities
Pharmacovigilance
Lead of Drug Safety for the DACH region
Stellvertretende/r Stufenplanbeauftragte/r (Deputy Graduated Plan Officer) for FUMADERM a ccording to §63a of the German Medicinal Products Act [AMG]
Product Complaints
Support other departments
Scientific congresses
Who you are
You possess a keen eye for detail and have a good understanding for business needs. You are able to change perspective, to effectively communicate with cross-functional teams to ensure compliance with safety regulations. You foster a culture of adherence to standards and pharmacovigilance guidelines within the Biotech industry and ensure that the organization remains compliant and operates effectively in a dynamic environment.
Qualifications
Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts
