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Pharmacovigilance Manager - Germany, Austria, Switzerland (DACH)

BeiGene | Homeoffice | DE

Welcome to the Latest Job Vacancies Site 2025 and at this time we would like to inform you of the Latest Job Vacancies from the BeiGene with the position of Pharmacovigilance Manager - Germany, Austria, Switzerland (DACH) - BeiGene which was opened this.

If this job matches your qualifications, please send your application directly through our latest Job site. Indeed, every job is not easy to apply because it must meet several qualifications and requirements that we must meet in accordance with the standard criteria of the Company who are looking for potential candidates to work. Good job information Pharmacovigilance Manager - Germany, Austria, Switzerland (DACH) - BeiGene below matches your qualifications. Good Luck: D

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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 BeiGenes 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 BeiGenes 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.

Information :

  • Company : BeiGene
  • Position : Pharmacovigilance Manager - Germany, Austria, Switzerland (DACH)
  • Location : Homeoffice
  • Country : DE

How to Submit an Application:

After reading and knowing the criteria and minimum requirements for qualifications that have been explained from the Pharmacovigilance Manager - Germany, Austria, Switzerland (DACH) job info - BeiGene Homeoffice above, thus jobseekers who feel they have not met the requirements including education, age, etc. and really feel interested in the latest job vacancies Pharmacovigilance Manager - Germany, Austria, Switzerland (DACH) job info - BeiGene Homeoffice in 2025-01-26 above, should as soon as possible complete and compile a job application file such as a job application letter, CV or curriculum vitae, FC diploma and transcripts and other supplements as described above, in order to register and take part in the admission selection for new employees in the company referred to, sent via the Next Page link below.

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Post Date : 2025-01-26

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