Associate Director, Dach Regional Drug Safety Lead

vor 6 Monaten

Munich, Deutschland Biogen Vollzeit

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 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

**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 a**ccording 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 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

**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 safety-related 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

  • Associate, Drug Safety Dach

    vor 6 Monaten

    Munich, Deutschland Biogen Vollzeit

    **Qualifications** For our Munich office (in a hybrid working model) we are recruiting for an **Associate, Drug Safety DACH (f/m/d)** in temporary employment via 3rd party. The position will be responsible to support all relevant PV activities within the DACH region. This includes but is not limited to routine activities as reconciliation activities,...

  • Associate Director Computational Chemistry

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Take advantage of your experience, establish agile research strategies, embrace collaborative design thinking, and actively shape a sustainable research project pipeline that addresses unmet medical needs. As drug discovery expert, you combine a drug discovery industry background with scientific expertise in computational chemistry. You...

  • Director/associate Vice President, Business

    vor 6 Monaten

    Munich, Deutschland Evotec Vollzeit

    Director/Associate Vice President Business Development (f/m/d) - Due to business growth, we have an incredible opportunity to join our successful globally recognised business development team. Are you currently an established senior business development professional within the _pharmaceuticals, biotechnology or Contract Research Services (CRO) drug discovery...

  • Associate Director

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: As an Associate Director for preclinical PK/PD Modelling and Simulation - Cardiometabolic, you will be an integral part of our multidisciplinary teams and drive our ‘learn-and-confirm’ mentality. You will improve your leadership skills and expand your own skillset by guiding PK/PD modelling scientists and project team representatives...

  • Regional Sales Director

    vor 4 Wochen

    Munich, Bayern, Deutschland Rochester Electronics GmbH Vollzeit

    Job ID: req1077Job SummaryRochester Electronics GmbH is seeking a highly motivated Regional Sales Director to drive business growth in the DACH territory. The successful candidate will work closely with the Internal Sales and Technical Sales teams to develop and execute sales business plans and strategies.Key ResponsibilitiesManage customer relationships and...

  • Director Clinical Safety

    vor 6 Monaten

    Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...

  • Senior Peptide Expert Drug Safety

    vor 5 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Peptide drugs are one of the most exciting areas in the pharmaceutical industry. You have experience in the non-clinical safety evaluation of peptide therapeutics and would like to contribute on an efficient development for optimal patient benefit? We offer the chance of a scientific leadership position within the department of...

  • Senior Peptide Expert Drug Safety

    vor 5 Monaten

    Munich, Deutschland Boehringer Ingelheim Vollzeit

    **The Position** Peptide drugs are one of the most exciting areas in the pharmaceutical industry. You have experience in the non-clinical safety evaluation of peptide therapeutics and would like to contribute on an efficient development for optimal patient benefit? We offer the chance of a scientific leadership position within the department of non-clinical...

  • Safety Physician

    vor 5 Monaten

    Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...

  • (Senior) Study Director

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: We offer you the opportunity to take on the role of Study Director/Scientist/Laboratory Head M/F/d for General Toxicology in our Nonclinical Drug Safety Germany department. This position includes conducting in vivo toxicology studies and provides exciting insights into areas such as Repeat Dose Toxicity and Reproductive Toxicity. In your...

  • Associate Director Patient Safety Reg Eu

    vor 6 Monaten

    Munich, Deutschland Sandoz International Vollzeit

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Associate Director – Strategy Germany Lead

    vor 4 Wochen

    Munich, Bayern, Deutschland Longevity Partners B.V. Vollzeit

    Job Title: Associate Director – Strategy GermanyLongevity Partners is a leading energy and sustainability consultancy and investment business. We are seeking a highly skilled Associate Director – Strategy Germany to join our Munich office.Key Responsibilities:Manage and develop the strategy teams in Germany, ensuring project completion, quality control,...

  • Partner Sales Director

    vor 6 Monaten

    Munich, Deutschland Apptio Vollzeit

    Overview: **Apptio, an IBM company, is the leading technology spend and value management software provider. Its AI-powered data insights empower leaders to make smarter financial and operational decisions. A pioneer and category leader in Technology Business Management (TBM) and FinOps, Apptio works with thousands of customers, partners, and community...

  • Leiter Drug Safety

    vor 5 Monaten

    Munich, Deutschland Klinikum der Universität München Vollzeit

    Das LMU Klinikum ist eines der größten und leistungsfähigsten Universitätsklinika in Deutschland und Europa. 48 Fachkliniken, Abteilungen und Institute mit einer exzellenten Forschung und Lehre ermöglichen eine Patientenversorgung auf höchstem medizinischen Niveau. Hieran sind rund 11.000 Mitarbeiterinnen und Mitarbeiter beteiligt. Ihr...

  • Regional Gsi Director

    vor 5 Monaten

    Munich, Deutschland Snowflake Vollzeit

    Build the future of data. Join the Snowflake team. Our EMEA Partners & Alliances organization is seeking a Regional GSI Director to join our growing team in Germany. GSI and RSI Partners offer consulting services and implement Snowflake in customer environments and refer new customers to Snowflake. We are looking for a self driven, go getter to help grow...

  • Sales Director, Dach

    vor 5 Monaten

    Munich, Deutschland Star Global Vollzeit

    **Munich, Germany**; **Hybrid** **The Company** Star is a global consultancy that connects strategy, design and engineering services to help companies accelerate product innovation. With over a decade of average 25% annual growth, we’re rapidly expanding our consulting services, geographic footprint and industry expertise. We’re on the cusp of further...

  • Sales Director, Dach

    vor 5 Monaten

    Munich, Deutschland Star global technology company Vollzeit

    Munich, Germany; Hybrid **The Company**: Star is a global consultancy that connects strategy, design and engineering services to help companies accelerate product innovation. With over a decade of average 25% annual growth, we’re rapidly expanding our consulting services, geographic footprint and industry expertise. We’re on the cusp of further growth...

  • Commercial Director

    vor 5 Monaten

    Munich, Deutschland Epsilon Vollzeit

    **Company Description** When you’re one of us, you get to run with the best.** For decades, we’ve been helping marketers from the world’s top brands personalize experiences for millions of people with our cutting-edge technology, solutions and services. Epsilon’s best-in-class identity gives brands a clear, privacy-safe view of their customers, which...

  • DACH Region Sales Director

    vor 5 Stunden

    Munich, Bayern, Deutschland 4screen Vollzeit

    About the RoleWe are seeking an experienced Sales Director to lead our sales efforts in the DACH region. As a key member of our team, you will be responsible for driving revenue growth, building and maintaining strong relationships with key decision-makers, and identifying new business opportunities.Key ResponsibilitiesDevelop and execute a sales strategy to...

  • Safety Director Physician

    vor 4 Wochen

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Safety Director Physician - Oncology Portfolio ManagementJob Summary:We are seeking a highly qualified Safety Director Physician to join our team at Daiichi Sankyo Europe. As a key member of our oncology portfolio management team, you will be responsible for developing and implementing global safety strategies and risk management activities for...