Pharmacovigilance Manager - Germany, Austria, Switzerland (DACH)

at  BeiGene

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The PV Manager DACH ensures that all local pharmacovigilance (PV) activities are performed as required by European and local legislation, as well as BeiGene’s process documents. The (Senior) PV Manager Germany & Austria acts as the contact person/subject matter expert for PV within the local organization for any PV matters, therefore being the interface with relevant local stakeholders e.g. General Manager, Medical Affairs, Commercial, Regulatory Affairs, Quality. They work closely with the Graduated Plan Officer in Germany and the PV Responsible Person in Switzerland to ensure oversight of the local PV system. In addition, any global PV initiatives are supported locally by the (Senior) PV Manager DACH to ensure local implementation in line with the global expectations and to be audit and inspection ready.

Essential Functions of the job:

• Follow up safety reports received from the countries, local safety report intake, translation and forwarding to the central case processing team
• Regulatory Intelligence in the countries (search, assessment, focus on PV regulations)
• Additional risk minimization measure management: version management, dissemination and tracking
• Review and support of Organized Data Collection Programs (Market Research, Non-Interventional Studies, etc.)
• Regular interactions with relevant stakeholders e.g. Regulatory Affairs, Quality, Commercial and Medical Affairs leadership in each country
• Audit and inspection support in the countries
• PV trainings in local language (internal, vendors)
• Monitoring of Patient Safety email addresses
• Review and update local procedural documents related to PV
• Interact with the Graduated Plan Officer / PV Responsible Person to ensure oversight of the local PV system
• Organization of local Patient Safety meetings including minutes
• Support the local PV risk action committee (Maßnahmenausschuss)
• Ensure filing and archiving of relevant safety documentation
• Support European PV initiatives of BeiGene’s QPPV Office

Qualifications:

• Scientific degree
• Expert knowledge of Good Pharmacovigilance Practices (GVP)
• Minimum of 2 years’ experience with Patient Safety
• In-depth, detailed working knowledge of the EU Good Pharmacovigilance Practices (GVP)
• Good command of Good Clinical Practice (GCP)
• Theoretical and practical knowledge of the performance of local PV activities, experience with PV audits and inspections on an affiliate/country level
• Excellent understanding of drug development and life-cycle management of medicinal products
• Minimum two (2) years of experience in biotech / pharmaceutical industry / service provider in PV / patient safety
• Ability to develop and influence relationships and partnerships (internal/external) across all levels of the organization
• Excellent oral and written communications
• Fluent in written and spoken German and English is a must
• Excellent interpersonal and customer service skills, and a high level of personal integrity
• Ability to anticipate strategic business needs based on regulatory or commercial changes to ensure the delivery of local PV activities and compliance
• Experience in networking and interfacing with external PV stakeholders and peers
• Strong analytic and strategic thinking skills with attention to detail
• Microsoft Office suit, Safety Database (Argus preferred), Document Management System (Veeva preferred)
• Travel: Up to 10%

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

• Follow up safety reports received from the countries, local safety report intake, translation and forwarding to the central case processing team
• Regulatory Intelligence in the countries (search, assessment, focus on PV regulations)
• Additional risk minimization measure management: version management, dissemination and tracking
• Review and support of Organized Data Collection Programs (Market Research, Non-Interventional Studies, etc.)
• Regular interactions with relevant stakeholders e.g. Regulatory Affairs, Quality, Commercial and Medical Affairs leadership in each country
• Audit and inspection support in the countries
• PV trainings in local language (internal, vendors)
• Monitoring of Patient Safety email addresses
• Review and update local procedural documents related to PV
• Interact with the Graduated Plan Officer / PV Responsible Person to ensure oversight of the local PV system
• Organization of local Patient Safety meetings including minutes
• Support the local PV risk action committee (Maßnahmenausschuss)
• Ensure filing and archiving of relevant safety documentation
• Support European PV initiatives of BeiGene’s QPPV Offic