What are the responsibilities and job description for the Safety Scientist position at Bavarian Nordic?
Protecting our tomorrow
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.
Safety Scientist
Your Responsibilities
- Accountable for Management of Global Clinical Safety and Pharmacovigilance (GCSP) 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 GCSP department
- Assist BN Safety Physicians
Skills & Requirements:
- Maintains accurate and complete knowledge of assigned investigational and marketed vaccines
- Supports Medical Safety Physician in product signaling review, analysis, delivery and approval
- Assist in the coordination and authoring of safety documents 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
- Responsible for the coordination and oversite of aggregate report and RMP tracking with safety physician input as needed
- 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
Education/Experience:
- Medical or natural sciences degree or background preferred
- MD, PA, or Advanced nursing degree
- 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 (ARGUS), MS Office and other relevant software
- Highly self-motivated individual able to work with a minimum of supervision
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.
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.
Salary Range for US - $123k – $180k USD
Locations:
- US Remote, East Coast preferred
- Ontario Canada
Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system.
If you are interested in the position, we look forward to receiving your application via our recruitment system.
Founded in 1994, we have 30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer.
Bavarian Nordic
#LI-MA1
Salary : $123,000 - $180,000
