(Senior) Physician - Clinical Safety and Pharmacovigilance (m/f/d)

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships and industry collaborations. The company was founded in 1994 and has been listed on the Nasdaq Copenhagen Stock Exchange since 1998. Headquartered in Kvistgaard, Denmark and with operations in Munich, Germany and North Carolina, USA, the company employs more than 400 people. Bavarian Nordic is an Equal Opportunity Employer.

For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.

To strengthen our Clinical Safety and Pharmacovigilance Department in Martinsried/Munich we are searching for a qualified

(Senior) Physician Clinical Safety and Pharmacovigilance (m/f/d)

Your Tasks

  • Analysis of comprehensive product information, synthesis, benefit-risk assessment and reporting
  • Proactive Monitoring of product safety profile from first in human throughout lifecycle
  • Primary ownership and accountability for product signaling review, analysis, delivery and approval – medical safety
  • Leadership and ownership of internal medical safety governance bodies
  • Active contribution to internal and external forums (e.g., DMC, Advisory Boards)
  • Contribute to label development, scientific regulatory responses
  • Provide medical and PV oversight and key input to: Protocols, Investigator brochures, Safety summaries, Clinical study reports, Regulatory reports (periodic, ad hoc), Labeling changes
  • Train drug safety personal and contribute to mentoring and on-boarding of new colleagues
  • Ensure all activities are of the highest medical safety, ethical and compliance standards
  • Manages all medical safety aspects of allocated studies and post market products
  • Oversee and maintain PVA/SDEA management, as well as CRO management in respect to medical safety processes, for example signal management
  • Ensures that all assigned medical safety activities are setup in line with the PV standard operating procedures (SOPs) and relevant guidelines
  • Serves as a contact for any product specific medical safety matters internally and externally
  • Directly report on overall product medical safety to the QPPV and other local persons for pharmacovigilance
  • PV Audit and Inspection preparation and support in respect to product specific medical safety aspects

Your Skills

  • Quality-oriented personality
  • In depth knowledge of GVP, FDA guidance documents and in general global PV legislation
  • Effective communication and negotiation skills, be able to work with matrix and local teams, and be able to break down problems to find solutions
  • Safety knowledge and data visualization skills

Your Profile

  • Degree in medical medicine, human or veterinary medicine
  • Minimum 2 years of work experience in medical safety
  • Fluent in German and excellent command of English with strong written and oral skills

Your Prospect

  • An exciting position within an international environment
  • Working in a highly motivated team
  • Broaden your experience in an internationally operating, biopharmaceutical company

Contact

If you are interested in the position, we look forward to receiving your application with your earliest possible start date and your salary expectations (annually) in English via our internal system.

Follow the direct link under view details and sign on. You will be redirected to our application form.

Bavarian Nordic GmbH
Fraunhoferstraße 13 • D-82152 Martinsried
www.bavarian-nordic.com

While applying for the job please refer to jobvector

About Bavarian Nordic GmbH

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases.
More about Bavarian Nordic GmbH