Join us at Vaccibody in this newly established role

We are currently seeking a Pharmacovigilance Manager who will have the overall responsibility for the safety strategy and surveillance of Vaccibody’s clinical development activities.

About the role

In this newly established position, you will ensure implementation and oversight of a compliant and validated Pharmacovigilance system, hosted either internally or externally. You will be overall responsible for developing and executing on the safety surveillance activities in clinical trials, contributing to development of trial related critical documents and act as the patient safety and pharmacovigilance expert towards clinical CROs and other collaborators and external partners.

The Pharmacovigilance Manager will act as the in-house expert with respect to patient safety reporting and pharmacovigilance activities across all development phases for Vaccibody’s vaccines. You will be a key member of cross-functional clinical trial teams and serve as ad-hoc member in project development teams providing safety and PV relevant guidance and input. Moreover, you will be responsible for establishing and managing Safety Committees and/or DSMBs and drive the development and update of Investigator Brochure(s) and safety reporting requirements for data generated in Vaccibody’s clinical trials. The role will report to Senior Director, Development Operations.

Job responsibilities

The responsibilities of the position include but are not limited to:

• Ensuring implementation of a compliant and validated Pharmacovigilance (PV) system and database for Vaccibody’s clinical safety data
• Set up of safety reporting processes, review CROs safety/PV related manuals and processes for Vaccibody’s clinical trials
• Act as Point of Contact for clinical CROs for safety and PV related tasks overseeing appropriate and timely handling of safety issues
• Provide input to clinical trial specific Risk Management Plans
• Perform ongoing surveillance of safety data from Vaccibody’s clinical trials and ensuring reporting is according to regulatory requirements
• Provide safety review and input to various trial related documents (trial synopsis, protocol, eCRF, Informed Consent Forms, Data Handling Plan et al.)
• Be responsible for input to and/or development of Investigator Brochures (IBs), periodic review processes and Development Safety Update Reports (DSURs/PSURs)
• Provide input to Data Exchange Agreements with vendors/partners
• Be responsible for establishing and managing Safety Committees or Data Monitoring Committees (DMCs) for Vaccibody’s clinical trials
• Plan and perform Safety Committee meetings and activities
• Contribute to the development and optimization of new tools and processes related to safety reporting and PV
• Stay up to date with newly issued relevant guidance documents and requirements and provide relevant training internally
• Ensure compliance with regulatory guidelines and internal processes and procedures
• Participate in audit and inspection activities as required
• Responsible for creation and maintenance of Vaccibody’s Safety and PV related SOPs in collaboration with QA

Education and experience requirements

• Master or PhD degree within medical, pharmaceutical science or equivalent
• Minimum 5 years of pharma/biotech/CRO experience within drug safety and/or pharmacovigilance
• Experience from drug development projects working in cross-functional teams and being responsible for safety related activities is desirable
• Profound experience from working with safety databases and pharmacovigilance systems
• Knowledge of MedDRA and ACT coding
• Previous experience from optimizing business processes, IT system testing and assessment
• Solid experience from clinical development activities and vendor management
• Knowledge about GDPR, data integrity and compliance in safety reporting activities
• Excellent analytical skills and a structured quality-focused way of working
• Profound knowledge about GCP and other related guidance
• English fluency required (verbal and written)

Who are we looking for?

When hiring new employees, we also look for the individuals who are inspired by Vaccibody’s entrepreneurial spirit and whom we think would be a good fit with our collaborative and inclusive company culture. For the candidate to succeed and thrive in this role, we believe that you are innovative and skilled in handling several projects at once. You enjoy working in various cross-functional teams as well as appreciate and engage in strategic discussions. With an eye for details and structure, a strong quality mindset and communication skills you manage to articulate your ideas and solutions to other team members and external partners. More importantly, you thrive in an international and dynamic environment.

Location: The person will ideally be positioned either in Norway or Denmark. However, the position may also offer a flexible working arrangement.

Deadline: 31.03.2021.

Applications will be reviewed after the deadline. We do not accept applications by mail.