Senior Pharmacovigilance Specialist

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

We are looking for a highly skilled Senior Pharmacovigilance Specialist with demonstrated experience in end-to-end case processing. In this role, you will be responsible for aiding the successful execution of developmental, non-development programs (e.g., Phase 1-4 studies, PASS, etc.), and post-approval programs by serving as the subject matter expert (SME), ensuring robust safety data collection for UTC products for proper management of benefit risk and overseeing case processing vendor(s).

Collectively, the group of PV specialists are accountable for the conduct of the development programs from the product safety side and end-to-end case management activities of adverse events (AEs), product complaints (PCs). and/or special reporting situations (SRSs) for our development/non-development programs. The Senior PV Specialist will develop, facilitate, and/or provide training and training materials for AE, PC, and/or SRS collection and reporting for developmental, non-development programs (e.g., Phase 1-4 studies, PASS, etc.) & post approval programs in accordance with SOPs, global regulations guidelines and conventions, as well as have oversight and management of vendors to ensure fulfillment of end-to-end case processing requirements in accordance with our company’s processes and global regulatory requirements.

Minimum Requirements

• Education and Experience Required:
  • Bachelor’s degree in a related field (chemistry or biology) or BSN and 5+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases & post-marketing reports)
  • Master’s degree in a related field (chemistry or biology) and 3+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases & post-marketing reports)
  • PharmD, PhD, MD/DO, or international equivalent and 0+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases & post-marketing reports)
• Prior clinical or post marketing experience
• Previous experience using Argus (preferred) or other safety databases
• Strong written and verbal communication skills, including but not limited to the ability to communicate safety issues in a variety of formats required to meet the needs of the intended audience and contributors
• End-to-end case processing (including data entry, QC, medical review, regulatory submissions)
• Working knowledge of drug development processes and activities, including but not limited to having the ability to explain the legislative framework supporting all aspects of Drug Development & registration of medicines, ensuring their safety
• Working knowledge of MedDRA coding
• Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, and drug products

Preferred Qualifications

• Master’s degree in a related field (chemistry or biology) or
• Doctor of Pharmacy (PharmD) PhD, MD/DO or international equivalent
• 3+ years of experience in vendor m