United Therapeutics Medical Director - Global Drug Safety and Pharmacovigilance in Durham, North Carolina

The Job Details are as follows:

What we do

United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market and a long-term mission of providing and unlimited supply of transplantable organs for those who need them. Our Company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

How you’ll contribute

The Medical Director serves as the product safety lead for assigned product and is responsible for the data review, analysis and medical evaluation of safety information to identify, characterize, and assist with development of mitigation for safety risks related to United Therapeutics products across the lifecycle of the product across all programs (Development & Post-development). The Medical Director will have a direct role in the pharmacovigilance and risk MGMT strategies/activities for the lifecycle of UTC products and is accountable for developing the PV strategy and the PV activities associated with UTC development & marketed products. The individual will be required to derive strong internal GDS collaboration & external (CROs) plus with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs & others support the lifecycle of products of their responsibility.

Key job responsibilities

  • Serve as a product safety level leader & point of contact for assigned UT product (internal & external).

  • Represent GDS in project teams and study teams for assigned UT products, and provide expert medical and safety knowledge regarding safety issues.

  • Collaborate closely with clinical development, clinical operations, and regulatory affairs, medical affairs teams to ensure alignment with risk management plans and collection of safety data.

  • Review and provide analysis for study related documents including IB, ICF, and safety management plans.

  • Perform/provide oversight for medical review of ICSRs from all sources for assigned product.

  • Develop and lead PV, benefit/risk assessment and risk MGMT strategies in collaboration with SRM team for the product of their responsibility.

  • Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR)

  • Participate in production and maintenance of risk management plans and safety communication (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties

  • Represent/participate GDS on safety monitoring teams as well as labeling committees as required (prepare, evaluate & review material to be present with Safety Risk Management).

  • Evaluate all safety data, provide input on signal detection activities, and continuously assess the benefit/risk ratio and design and implementation of risk management & mitigation activities for the product of their responsibility.

  • Responsible for medical coding review and publishing of guidelines to ensure regulatory compliance.

  • Responsible for collaboration & review of CSR narratives & provide feedback to medical writers in timely manner.

  • Creates and executes product-focused strategy learning sessions for the internal teams

  • Collaborate with GDS Ops, SRM & Compliance & inspection readiness team to support documentation needs.

  • Responsible for review of medical Info letters, other DHCP & outward communication.

For this role you will need

  • Medical degree/MD

  • Minimum two (2) years in either clinical practice or relevant setting, clinical research experience

  • Minimum one (1) year in pharmaceutical industry (clinical research, pharmacovigilance, or Medical Affairs) or equivalent

  • Knowledgeable in medicine and pharmaceutical product safety

  • Experience applying medical knowledge to the interpretation of individual case review

  • Previous experience in the safety field and/or pharmaceutical industry

  • Previous experience reviewing and/or contributing to PBRERs, DSURs, PADERs, and other safety surveillance reports

  • Proficiency with Microsoft Excel required

  • Excellent oral and written English skills

  • Ability to build and manage inter-relationships by motivating and inspiring others

  • Experience working in a team environment, including supporting other team members when necessary; promote collegiality and teamwork among peers

  • Ability think clearly and decisively and present independent, reasoned solutions to identified safety issues, helps to drive consensus, and catalyzes action to meet critical regulatory objectives

  • Demonstrated creative problem-solving skills that enact change and drive continuous improvement

  • Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment

  • Ability to build and manage inter-relationships by motivating and inspiring others

  • Ability to operate with minimal direction

  • Experience with medical writing preferred

  • Experience in Argus safety database is preferred.

Life as a Unitherian

At United Therapeutics you’ll realize quickly that it is not an ordinary place to work! When you join our Company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level of job performance and provide state of the art facilities to flourish. This is what makes united Therapeutics a stimulating place to work.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.