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Senior Medical Director, Global Drug Safety and Pharmacovigilance

Company: United Therapeutics
Location: Durham
Posted on: January 14, 2019

Job Description:

The Job Details are as follows: Senior Medical Director (Cardiopulmonary) Position Overview The Senior Medical Director plays a global role in designing and implementing safety strategies at a product portfolio level and serves as a global product safety lead overseeing the activities of other product safety leaders within GDS/PV. This position provides scientific expertise/recommendations with respect to product level benefit risk to ensure safe use of product of their responsibility. The Senior Medical Director will also be responsible for ensuring the product matrix organization within GDS is functioning as designed and will serve as a product safety expert in the company matrix team interacting with Clinical Operations, Regulatory Affairs, Medical Affairs, and Quality Assurance. Key Accountabilities / Responsibilities + Oversee deliverables of the product matrix team assigned & ensure support and execution of goals set forth by Head of GDS. + Collaborate with Head of PV Medical to design strategies to support the pharmacovigilance team to support scientific underpinning in all aspect of PV activities. + Collaborate with VP of GDS to ensure GDS vision & mission along with compliance with GvP regulations, departmental procedures and Company policies. + Provide clinical & pharmacological expertise in project teams involved in the development programs in the conduct of PV. + Responsible for safety issue management through life cycle management (development & post approval). + Develop and lead PV, benefit/risk assessment and risk management strategies in collaboration with SRM team for UTC products. + Provide expert medical input to trial and project level DSMB, Safety Adjudication committee activities for projects/products. + Strategize and formulate models for evaluating the potential impact of risk management interventions intended to optimize product benefit/risk. + Provide leadership on clinical safety content of marketing applications (e.g. NDA/MAA Clinical Safety Summary and Risk Management Plan). + Responsible for responses to inquiries from regulatory authorities or HCPs on safety issues (development & post approval). + Accountable and responsible for designing and executing strategy supporting medical review of ICSRs from all sources for portfolio of product(s). + Oversee, create and execute product-focused strategy, learning sessions for the internal teams and contractors supporting case processing function as well as for commercial and medical affairs colleagues. + Collaborate with GDS Case Management, SRM & Compliance & inspection readiness team to support documentation needs. Minimum Education and Experience Required + Medical degree (MD) + Extensive clinical knowledge within the cardiopulmonary therapeutic area with a minimum of 2 years in either clinical practice, clinical research or other relevant setting + Minimum 10 years in pharmaceutical industry (clinical research, pharmacovigilance, or medical affairs) or equivalent with a minimum 5 years in direct pharmacovigilance and/or drug safety + Experience working in a team environment, including managing and coaching other team members when necessary; promote collegiality and teamwork among peers. + Previous experience reviewing and/or contributing to PBRERs, DSURs, PADERs, and other safety surveillance reports + Experience with medical writing Knowledge, Skills, and Abilities + Advanced Excel skills for generation of analyses and reports + Works effectively with colleagues and facilitates achievement of common goals + Works effectively in ambiguous situations + Ability to develop long and short-range plans to accomplish business goals; monitors performance against plans and objectives + Intermediate analytical thinking: diagnoses situations, gathers and reviews relevant information, and recommends solutions + Ability to lead medium to large projects + Knowledgeable in medicine and pharmaceutical product safety + Competent in safety review of clinical safety documents including AEs/SAEs, IBs, protocols, CSRs, and informed consent documents + Competent in safety reviews of post-marketing safety documents, including spontaneous reports and other ICSRs, periodic safety reports, risk management plans, and company core safety information + Knowledge of GVP, GCP, ICH guidance and global regulations + Knowledge of current benefit-risk principles + Ability to present reasoned solutions to identified safety issues and catalyze action to meet critical regulatory objectives + Demonstrated creative problem-solving skills that enacts change and drives continuous improvement + Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment + Ability to build and manage relationships by motivating and inspiring others + Excellent interpersonal and time management skills. + Ability to operate with minimal direction + Excellent oral and written English skills 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.

Keywords: United Therapeutics, Durham , Senior Medical Director, Global Drug Safety and Pharmacovigilance, Healthcare , Durham, North Carolina

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