Global Drug Safety & Pharmacovigilance Compliance Director

Genmab A/S

Ph.d. & forskning
Storkøbenhavn

Global Drug Safety & Pharmacovigilance Compliance Director

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

Genmab is expanding the Safety and Pharmacovigilance area and now looking for a Global Drug Safety & Pharmacovigilance Compliance Director.

As Global Drug Safety & Pharmacovigilance Compliance Director you will be primarily responsible for providing compliance management on all aspects and activities within Global Drug Safety and Pharmacovigilance group. The compliance oversight includes but is not limited to PV Compliance oversight, audit/inspection readiness, CAPA management, partner agreements and oversight, PV Intelligence, SOP maintenance, PV training compliance and basic PV training.

As a Global Drug Safety & Pharmacovigilance Compliance Director you will be part of a highly skilled and international team in Denmark and US. The position reports to the Head of Global Drug Safety and Pharmacovigilance.

Responsibilities

The key responsibilities for this role will be, but not limited to:

  • Ensure appropriate management of all global pharmacovigilance procedures working closely with global colleagues from other departments/regions as applicable.
  • Ensure compliance with regulatory authority guidelines and regulations as well as keeping abreast of Pharmacovigilance methods and trends in published literature and global regulations.
  • Manages and maintains all global pharmacovigilance policies, procedures and workflow, including development and implementation of SOPs and other controlled procedure and documents to support investigational and marketed product safety surveillance.
  • Oversee the compliance of the day to day operation of PV vendor (s).
  • Provide support to the PV team with compliance oversight relevant to the regions in compliance with current regional regulations, internal and external guidance documents, and Standard Operating Procedures.
  • Manage and oversee the CAPA process resulted from compliance monitoring and work closely with Global QA to address and document responses.
  • Manage the negotiation process, implementation and compliance oversight of exchange of safety data with contractual partner counterparts.
  • Contribute to the safety training for all relevant internal and external team members.

Requirements

  • Advanced degree in healthcare related field with a minimum of ten years of relevant experience in Pharmacovigilance/Clinical Research.
  • An excellent knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of post marketing spontaneous and clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports.
  • Must be knowledgeable with FDA/EMA/PMDA/ICH requirements, good clinical practices, and pharmaceutical clinical development.
  • Excellent knowledge of safety data base systems and the report generation capabilities.
  • Excellent written and verbal communication skills.

Moreover, you meet the following personal requirements:

  • Strong interpersonal skills and ability to manage, motivate and influence work behaviors of individuals who are not direct reports.
  • Highly organized, outcome oriented, problem solving, understanding of research methods and basic data analysis, excellent teamwork, and strong communication skills.
  • Demonstrated ability to work independently as well as collaboratively with other team members.
  • Must be able to communicate effectively regarding safety data, and issues related to safety and pharmacovigilance.
  • Innovative, think outside the box and self-motivated.
  • You are result-and goal-oriented and committed to contributing to the overall success of Genmab.

If you have any questions, please feel free to reach out to Recruiter, Michele Vantaggi, at miv@genmab.com (US) or Jannie Jensen at jjn@genmab.com (DK).

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.


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Ph.d. & forskning
Storkøbenhavn
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Naturvidenskab
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