Safety Scientist
Bavarian Nordic A/S
Protecting Our Tomorrow
At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox/mpox vaccines, and our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization. We aim to improve health and quality of life for children and adults around the world – protecting our tomorrow. We hope that you will share this mission with us.
Your Responsibilities
- Accountable for Management of Clinical Safety and Pharmacovigilance (CSPV) at Bavarian Nordic (BN)
- Close interaction with other departments across BN (Clinical (Clinical Operations, Data Management), Regulatory, Quality Assurance, Commercial, Manufacturing) and any partners/vendors
- Contribute to development and maintenance of SOPs, policy documents and processes relevant to PV and for the safety database
- Oversight and maintenance of Pharmacovigilance (PV) standards within CSPV department
- Assist BN Safety Physicians
Skills & Requirements
- Medical or natural sciences degree or background preferred
- Advanced nursing degree, M.Sc., PhD, MD
- Minimum of 5 years’ experience in PV in the biotechnology/pharmaceutical industry or service providers/CROs or advanced degree and 3 years of experience in the biotechnology/pharmaceutical industry
- Knowledge of domestic and international laws, regulations and policies governing pharmacovigilance
- Excellent command of English with strong written and oral skills, including experience in medical and regulatory terminology (MedDRA)
- In-depth knowledge and skills in the use of database applications, MS Office and other relevant software
- Highly self-motivated individual able to work with a minimum of supervision
Tasks
- Assist medical safety team in product signaling review, analysis, delivery, and approval
- Assist medical safety team with the development of RMP, ISS, and aggregate report generation
- Assist in the coordination and authoring of safety evaluations and responses to safety inquiries from internal and/or external stakeholders
- Serve as a core member of the Safety Management Team providing necessary data outputs, preparing presentations and safety analyses, assisting with safety related activities associated with regulatory filings, benefit-risk assessment and safety risk management
- Manages all PV aspects of studies (including Investigator sponsored studies) and post market products
- Oversees and maintains pharmacovigilance agreements/safety data exchange agreements (PVA/SDEA), as well as CRO management in respect to PV; overall contract management with PV relevance oversight
- Ensures that all assigned projects are set-up in line with the PV standard operating procedures (SOPs) and relevant guidelines
- Serves as a contact for any PV matters internally and externally
- PV audit and inspection preparation and support
- Support in preparing publications and presentations
We offer
A chance to work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies. We offer a comprehensive benefits plan and a competitive compensation package.
Location
: Remote
Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.
Department: Philip Heyman's Allé 3, Hellerup
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