Director of Patient Safety/Pharmacovigilance

Regulatory Affairs/Clinical Affairs Minneapolis, Minnesota


Descripción

At Padagis our focus is on health care products that improve people’s lives. We are experts on extended topical products and are strategically investing to expand our #1 position in the extended topical category in the United States. Our team members, numbering more than 1,300 work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Join our team where great things are happening and you can make a difference.

This Director of Patient Safety/Pharmacovigilance directs the creation, implementation and provides global oversight of Padagis’ Global Patient Safety Programs to assure the company meets its business priority of assuring user safety throughout the entire lifecycle of the products and services offered by the company.  Advances the safe use of the products and services and ensures alignment with business objectives and goals.  Is the primary contact for 3
rd party providers tasked with product complaint intake, triage, and pharmacovigilance activities.  Pharmacovigilance responsibilities include the design, execution and implementation of Pharmacovigilance systems to assure proper gathering, evaluation, assessment and follow up of individual and aggregate medical events.  Act as primary medical reviewer of adverse events, safety summary and signal detection and generation.   Provides advice to and sets strategy with the executive management on patient safety and labeling issues.  Ensures product quality investigations are thorough and timely and conducts periodic trending with escalation when adverse trends are identified. 

 Knowledge, Experience and Education: 

  • Medical degree (ie. MD, RN, PharmD) combined with clinical experience is required.
  • Training and/or experience in pharmacology, epidemiology, biostatistics, toxicology or clinical research is strongly preferred.
  • Minimum of 12years of progressively responsible drug safety leadership experience in the pharmaceutical industry is required and four (4) years leadership roles within a pharmacovigilance functions also required.
  • Leadership experience in a global, diverse, multi-cultural organization is required.
  • Previous experience developing and implementing global patient safety systems.
  • Ability to analyze business issues and understand implications of product safety and health hazard evaluations and risk-based decisions.
  • Must possess comprehensive knowledge of state, federal, international and other regulations governing pharmacovigilance and drug safety practices.
  • Exceptional leadership and communication skills, including well-developed interpersonal skills and strong written communication skills.
  • Demonstrated ability to manage and develop teams (both locally and with 3rd party providers).
  • Demonstrated ability to manage senior executive relations and ability to collaborate and build relations with stakeholders across functional and organization lines, and enterprise-wide program development and management skills.
  • Knowledge of and experience with technology tools to support the quality function including excellent computer skills in Microsoft Suite environment.


#Padagis

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.