Global Patient Safety Affiliate, Alliance, & Contracts Senior Manager

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

Do you have a deep understanding of pharmacovigilance (PV) regulations globally and their operational implications for a wide range of product types (drug, combination, device reporting obligations) and relationships (partner, vendor, distributor, etc.)? Are you experienced with managing PV contracts lifecycle? Our ideal candidate will be organized, collaborative, and skilled at building strong relationships across functions.

This role is responsible for management of Global Product Safety & Pharmacovigilance business alliance activities and contribution to AA&C projects and initiatives. This includes partner relations, management of vendors and partners, compliance with respective Pharmacovigilance Agreements (PVAs) and Vendor Oversight Plans (VOPs), and interfacing with corporate quality team pertaining to audits, corrective and preventative actions plans (CAPAs) and other activities.
 

Minimum Requirements

• Education and Experience requirements:
  • Bachelor’s degree in a related discipline with 10+ years of experience in healthcare or life sciences industry, or
  • Master’s degree in a related discipline with 8+ years of experience in healthcare or life sciences industry, or
  • Doctor of Pharmacy (PharmD) with 5+ years of experience in healthcare or life sciences industry
• 5+ years of pharmacovigilance experience
• Working legal knowledge of PV contracts and contract execution
• Continually reviews internal and vendor processes and performance and identifies opportunities for improvement and efficiency gains; generates creative solutions to business challenges and fosters innovation
• Working knowledge of drug development processes and activities
• Basic analytical thinking; diagnoses complex situations with broad impact and exercise sound judgment in recommending solutions
• Detailed understanding of relevant vendor operational processes
• Advanced skills in third party contracting and management processes
• Solid understanding of audit processes, planning, and readiness activities
• Advanced medical and scientific writing; ability to convey, legal, medical and scientific concepts clearly and effectively

Preferred Qualifications

• 1+ years of paralegal experience and Legal experience of PV contract management OR 1+ year of relevant quality PV management / support experience

Job Location & Travel

This position is based in our Durham, NC office, however we will consider a remote position for the right candidate. This position will travel up to 10% if based in the Durham office, and up to 20% if located remotely.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

The salary for this position ranges from $144,000 to $180,000 per year. (In addition, this role is eligible for the Company’s short-term and long-term incentive programs- may not