Sr. Director, Pharmacovigilance & QPPV

This is a new and exciting position with influence, responsibility, possibilities in a rapid growing company. Y-mAbs offer you an exciting work environment within pediatric oncology where challenging assignments will come your way.

Y-mAbs is an international, listed biotech company based in Hoersholm and New York with two late stage development programs and an exciting pipeline. Y-mAbs also initiates several new clinical trials in both Europe and US. Y-mAbs mission is to become the world leader in developing better and safer antibody-based pediatric oncology products addressing clear unmet medical .

Y-mAbs aim for regulatory BLA submissions of the two most advanced late stage programs within a short time frame to be followed by European marketing applications.

Y-mAbs A/S is searching for an experienced Senior Director, Pharmacovigilance (PV) to be responsible for the implementing and co-ordination of Y-mAbs post marketing PV system including, establishment of PV SOPs internally, external vendor selection, PV oversight and to hold the QPPV function. It is the intension to work via an external contract vendor for PV function.

This is a new and exciting position with influence, responsibility, possibilities in a rapid growing company. Y-mAbs offer you an exciting work environment within pediatric oncology where challenging assignments will come your way.

Job contents:

The position will be at the Sr. Director level and will report to the Chief Medical Officer. You will be based in the Danish headquarter in Hørsholm.

As you will be the first hire, you will be responsible for Post Marketing PV. You will be the “key” to set up structure and oversight of vendor/chose vendor, Pediatric oncology, and orphan drug environment.

Further the responsibilities include:

• Developing and implementing SOPs and other controlled documents to support marketed product(s) safety surveillance.
• Establish the PV department infrastructure (including vendor selection/ oversight).
• Act as single contact point for Competent Authorities on a 24/7 basis.
• Maintain and manage oversight of Y-mAbs PV system, including set up/ oversee implementation of the Pharmacovigilance System Master File (PSMF) as mandated by current regulatory guidance.
• Setting up/ oversee implementation of Risk Management File (RMF) and/or Risk Evaluation and Minimization Strategies (REMS) documents.
• Responsible for review of periodic reports and reports of post-authorization safety studies.
• Hold QPPV function upon expected EU approval for 1 or more compounds.
• Collaborate with QA to establish and maintain an adequate quality management system for pharmacovigilance.

Professional Qualifications:

• Certified MD, with minimum 8 years of experience from the drug safety area in the biotechnology/pharmaceutical industry.
• Expert knowledge of Good Pharmacovigilance Practice (GPvP) requirements for marketed products. Strong working knowledge of GCP requirements.
• Experience with post marketing PV and experience with US will be advantage.
• Knowledge of international laws, regulations and policies governing Pharmacovigilance.
• Experience with oncology would be beneficial.
• Previous experience holding a QPPV function an advantage.
• Excellent command of English with strong written and oral skills, including experience in medical and regulatory terminology (MedDRA)

Personal Qualifications:

• You are hands on, and also an experienced person with a strategic mindset.
• Demonstrates initiative and capacity to work under pressure
• You are at team player and very good in communication and knowledge sharing.
• You are result-oriented and committed to contributing to the overall success of Y-mAbs.
• Capability to synthesize and critically analyze data from multiple sources

Application and more information:

For more details about the job, please contact Hanne Beirholm,Beirholm Search, at +45 29440080. Please note that all applications must be submitted in English and will be treated confidentially. Please submit your CV at the link.