Medical Scientist as (Senior) Specialist - 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) Specialist Clinical Safety and Pharmacovigilance (m/f/d)

Your Tasks

  • Supports to manage all clinical safety (CS) and pharmacovigilance (PV) aspects of allocated studies and post market products
  • Supports PVA/SDEA management, as well as CRO management in respect to CSPV
  • Contributes to set up all projects in line with the CSPV standard operating procedures (SOPs) and relevant guidelines
  • Ensures collection, submission and filing of all safety data/case processing and global safety database maintenance support; including serious adverse event (SAE) reports from clinical trials, spontaneous reports for marketed products and reports from the literature, as well as any social media surveillance
  • Contributes to signal management
  • Follows up on Key Performance Indicators for the PV system and continuously monitors global PV system compliance
  • PV Audit and Inspection preparation and support
  • PV training support
  • Literature search and review
  • PV administration and PV team support tasks, including CSPV meeting preparation, minutes and action item follow up

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

  • Medical degree or background preferred
  • Minimum 2 years of work experience in the pharmaceutical or biotech industry, preferably in the area of pharmacovigilance and/or clinical research
  • In-depth knowledge of Office standard applications (Word, Excel, PowerPoint)
  • In-depth knowledge of database systems and document management solutions, preferably in the pharmacovigilance area
  • Broad knowledge of PV, especially post marketing
  • Audit and Inspection experience is desirable
  • Experience in PV compliance management would be an asset
  • Fluent in German and excellent command of English with strong written and oral skills
  • Basic knowledge of international drug legislation

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

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Über 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.
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