Associate Director, Dach Regional Drug Safety Lead - Munich, Deutschland - Biogen

Biogen

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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

Collection, documentation and any further local processing of adverse event and pregnancy reports
Collection, review and evaluation of safetyrelated scientific literature and other sources of information
Signal detection activities for Fumaderm
Support authoring RMP, PSUR, DSUR and any other documents for Fumaderm
Cooperation 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

Lead of Drug Safety for the DACH region

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

Stellvertretende/r Stufenplanbeauftragte/r (Deputy Graduated Plan Officer)
for FUMADERM according to -63a of the German Medicinal Products Act [AMG]**- Set up and manage a pharmacovigilance system

Collect and evaluate notifications on medicinal product risks that have become known and coordinate 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 riskbenefit profile of a medicinal product, including his/her own evaluations, are sent immediately and in full, if requested by the competent higher federal authority

Product Complaints

Support processing of and following up on product complaints

Support other departments***- 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 safetyrelated knowledge within the department and across company departments and divisions

Scientific congresses

Attend national/international pharmacovigilance and medical congresses, as needed

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

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

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.

Read on to learn more about our DE&I efforts