Drug Safety Manager

Affibody AB is expanding its clinical development programs, moving into Phase 2 and 3, and therefore sees a need to develop and strengthen the company’s capabilities within Drug Safety. Currently Affibody is looking to recruit a Drug Safety Manager, with the potential to also support the closely related area Regulatory Affairs. The role will report to the Head of Clinical Development and the location is at our newly established premises in Solna.

The role in general

The role is responsible for managing and delivering key tasks in the area of Drug Safety. Drug Safety is a capability that Affibody currently is developing so the holder of this role will be a key player in building up this function within the company. Operational safety tasks such as case reporting and maintenance of the safety database is outsourced to an external partner. Tasks as part of the role will include the development and maintenance of efficient working processes towards the external partner to ensure safety oversight regarding safety reporting and signal detection within the ongoing development programs as well as supporting the internal project teams regarding drug safety matters. The role will also cover tasks such as coordination and authoring of annual safety reports and other safety summaries. In addition, depending on the profile and interests of the successful candidate or as a development opportunity, the role could also include regulatory affairs tasks in relation to clinical trial applications (CTAs) and orphan drug designation (ODD) applications, as well as preparation and coordination of tasks related to scientific advice procedures.

Main responsibilities within Drug Safety include:

  • Contribute to the development and maintenance of working processes for Drug Safety
  • Key contact to the external safety provider
  • Analysis and presentation of aggregated safety data for signal detection
  • Support safety oversight and benefit risks assessments
  • Complete safety update reports and other safety summaries both internally and in collaboration with the external safety partner
  • Deliver analyses and safety data packages to the projects, or research management
  • Provide drug safety expertise to study team physicians, project teams and management
  • Coordinate and author risk management plans
  • Keep up to date within the area of Drug Safety, including new regulations and guidelines

Additional responsibilities within Regulatory Affairs may include:

  • Task related to CTAs, investigational new drug (IND) applications, ODDs etc.
  • Medical writer tasks in relation to regulatory documents such as Investigator’s Brochure, CTA/IND documents etc.
  • Prepare briefing documents for scientific advice meetings with regulatory agencies

Qualifications

The right candidate fulfills the following qualifications:

  • University degree within life science e.g. chemistry/biology, biotechnology, medicine, pharmaceutical sciences, and a minimum of 5 years of experience in the pharmaceutical industry, including experience from Drug Safety. Experience from Regulatory Affairs is a plus.
  • Knowledge of pharmacovigilance and signal management tools, analysis and reporting of medical safety issues
  • Knowledge of the global pharmacovigilance and regulatory requirements (e.g. US and European Legislation)
  • Analytical and organizational skills and ability to apply sound judgment in interpretation of safety-related data
  • Experience from medical writing
  • Excellent verbal and written communication skills in English
  • Strong communication/interpersonal skills
  • Experience from early drug development projects is desirable

Personal attributes

We are looking for a thorough and well-organized individual who is able to work independently, as well as in teams. To be successful in the role you need to be flexible and willing to take on various tasks in a multidisciplinary environment. You provide sound solutions to problems and identify with whom to communicate and interact. The role requires both operational management and strategic oversight. You have the ability to prioritize in order to deliver business critical items in time.

Application

In this recruitment we are collaborating with Haeger & Carlsson. Please apply through www.haegercarlsson.com. If you have any questions about the role, please contact Gunilla Haeger, 070-461 93 87, gunilla@haegercarlsson.com or Rolf Carlsson, 070-316 12 68, rolf@haegercarlsson.com

Affibody in short

Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.

Upcoming reports Financial calendar

  • Interim Report January to March 2020 (May 15, 2020)
  • Interim Report January to June 2020 (August 21, 2020)
  • Interim Report January to September 2020 (November 13, 2020)
  • Year End Report 2020 (February 2021)