Drug Safety Advisor

Join us in making a difference for people with allergy

ALK, a global leader in allergy immunotherapy, is looking for 2 new colleagues in Safety Surveillance. As drug safety advisor or principal drug safety advisor, you are making a difference every day for people with allergy by surveying the safety of ALK's products.

About the job

As a drug safety advisor, you will have plenty of responsibility, interdisciplinary collaboration, and stakeholder management. The overall responsibility of the drug safety advisor is to contribute to safety management throughout the product lifecycle in accordance with regulatory requirements and in collaboration with internal stakeholders.

Your responsibilities include

• Performing scientific review of individual safety case reports
• Performing signal detection and benefit-risk assessments
• Writing periodic safety update reports
• Providing input to safety-related enquiries
• Conducting regular safety monitoring of ongoing clinical trials
• Assisting in writing of safety sections of clinical trial protocols, Investigator Brochures, clinical trial reports, and regulatory dossiers

About you

You have a relevant university degree in life sciences (e.g., PhD, MSc., DVM, MD). You have experience from a pharmaceutical, medical device or biotech company, as a freelance consultant or from regulatory authorities, where you have worked with drug safety/pharmacovigilance, (safety) medical writing, or clinical development.

You should be attracted by the opportunity of being part of a small team (9 drug safety advisors), the opportunity to develop the role as well as contributing to the development of the team and the company.

Professional competencies

• Solid understanding of medical concepts and scientific methodology
• Excellent writing/communication skills
• Strong analytical skills
• Stakeholder management skills
• Fluent in English, both written and spoken
• Advanced computer skills; MS Office, Adobe Acrobat
• Knowledge of GCP and GVP

Personal competencies

• Self-driven and with a high level of motivation
• Assertive and positive attitude with a good sense of humour
• Helpful and supportive team player, where no task is considered trivial
• Capable of taking responsibility and ownership of tasks
• Flexible, open-minded, and innovative
• Detail-, and quality-oriented, and with a sharp eye for accuracy
• Pro-active, well-organised, and with good oversight

We offer

A job with considerable individual responsibility, challenges, and the opportunity to develop your professional and personal competencies. There are 2 positions open: 1 permanent and 1 temporary maternity leave position running until summer 2022 with the possibility for extension.

ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The team is driven by a high level of professionalism, integrity, an open-minded approach, where everyone contributes to an inspiring and fun working environment, and where the key values are patient safety, teamwork, and trust.

Application deadline

1 August 2021.

Contact

For further information on the position please contact, Head of Safety Surveillance, Hanne Hedegaard Villesen @ +45 4190 4423.