Senior Specialist Clinical Safety And Pharmacovigilance (Cspv)

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.

Specialist/ Senior Specialist, Clinical Safety & Pharmacovigilance

The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in the USA and globally. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.

You would add your Clinical Safety and Pharmacovigilance expertise as your depth knowledge of the PV legislation to the team, supporting with compliance, pharmacovigilance system master file maintenance, contract management, overview of worldwide pharmacovigilance activities and vendor management, maintaining the quality and high standards of the pharmacovigilance processes among other activities.

We are looking for an analytical thinker who can handle complex data, build up structured processes and communicate information across a global team alike.

Your Responsibilities

• Overall accountability for management of CSPV at Bavarian Nordic (BN)
• Close interaction with other departments across BN (Clinical (Clinical Operations, Data Management), Research, Regulatory, Quality Assurance, Commercial, Manufacturing/CMC) and any partners/vendors
• Oversight and maintenance of Pharmacovigilance (PV) standards within CSPV Department
• Management of Standard Operating Procedures, policy documents and processes relevant to PV and cross-departmental throughout process life cycle management
• Oversight of safety management in order to support the benefit-risk profiles of all BN products
• Oversight of safety management across clinical studies
• Oversight of handling of adverse event reports received at BN
• Oversight of expedited reporting to regulatory authorities according to current regulations
• Mentor/Train other BN PV staff/ contractors / vendors
• Pharmacovigilance System Master File Management
• Overview of Clinical and Safety Pharmacovigilance vendors/ CROs
• Global and Local Compliance Management
• Support Snr. Manager in the pharmacovigilance operations and compliance

Your Qualifications

• Academic degree in natural sciences, preferably medical degree/background
• Minimum of 5 to 7 years’ experience in PV in the biotechnology/pharmaceutical industry or service providers/Clinical Research Organizations (CROs)
• 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 (Medical Dictionary for Regulatory Activities -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

Oversee more junior functions on below referenced tasks, as well as taking a lead and final review and approval function in/for below referenced tasks, if not specified by other function assignment differently:

• Manages all PV aspects of studies (including Investigator sponsored studies) and post market products
• Support Snr. Manager with Pharmacovigilance System Master File Management, with Pharmacovigilance Agreements (PVA)/Safety Data Exchange Agreements (SDEA) management, as well as CRO management in respect to CSPV; overall contract management with PV relevance as requested
• Overview of Clinical and Safety Pharmacovigilance vendors/ CROs
• Global and Local Compliance Management, establishing and maintaining key Performance Indicators (KPI) for the PV system and continuously monitors the global PV system compliance
• Quality Management activities: Ensures that all assigned projects are set-up in line with the PV standard operating procedures (SOPs) and relevant guidelines, PV Audit and inspection preparation and support, PV training maintenance and on job training for PV Staff as requested per the Snr. Manager and contributes to writing and review of BN internal quality system documents
• Directly reports on overall PV compliance to the (Snr.) Manager PV and the European Qualified Person Responsible for PV (EU QPPV)
• Support the Snr. Manager with the EU QPPV office and local persons for PV (Local Person Responsible for PV) network management
• Serves as a contact for any PV matters internally and externally as per requested by Snr. Manager
• Maintenance of PV Regulatory Intelligence
• Support in preparing publications and presentations

Salary - $100 - $130k

Location – US Remote

We offer

We offer a chance to work in an international company with unique technology and a dedicated workforce. We offer a dynamic work environment and an opportunity to develop both your personal and academic competencies. We have a dynamic, modern, and attractive workplace at Bavarian Nordic with room to find the ideal work-life balance.

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.