Associate Director, Postmarketing PV Case Management

United Therapeutics; United States; Remote; USD 163,000 - 185,000; Full time

Job summary

An established industry player is seeking a passionate Associate Global PV Case Management Director to oversee pharmacovigilance activities. This role is vital for ensuring compliance and efficiency in safety data management across a diverse global product portfolio. With a commitment to innovation and patient care, the company offers a dynamic environment where your expertise in case processing and regulatory compliance will make a significant impact. Join a team that values creativity and collaboration, and contribute to groundbreaking solutions in the biotech sector. This opportunity promises not only professional growth but also the chance to be part of a mission that transforms lives.

Benefits

Medical coverage

Dental coverage

Vision coverage

Prescription coverage

Employee wellness resources

401k savings plan

Employee Stock Purchase Plan (ESPP)

Paid time off

Paid parental leave

Disability benefits

Qualifications

• 12+ years of experience in pharmacovigilance with a bachelor's degree.
• Strong knowledge in end-to-end case processing of ICSRs.

Responsibilities

• Manage end-to-end case safety management for global products.
• Ensure compliance with global regulations and guidelines.

Skills

Pharmacovigilance

End-to-end case processing

Data entry

Quality Control

Medical review

Regulatory submissions

Vendor management

Education

Bachelor’s degree in nursing

Bachelor’s degree in chemistry

Bachelor’s degree in biology

Master’s degree in chemistry

Master’s degree in biology

PhD/PharmD/MD/DO

Tools

Argus

Job description

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

You have been responsible and are a SME on end-to-end case processing for post-marketing products, including combination products. You are passionate about PV and enjoy being part of a collaborative team.

The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position strategizes and implements plans to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency, quality, and compliance impacts. This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products.

Minimum Requirements

• Bachelor’s degree in nursing, or chemistry, biology, or related field
• 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree or
• 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a master's degree or
• 7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a PhD/PharmD/MD/DO/or international equivalent
• Previous experience using safety databases, preferably Argus
• End-to-end case processing, including data entry, QC, medical review, and regulatory submissions

Preferred Qualifications

• Master’s degree in chemistry, biology, or related field, or
• Doctor of Philosophy (PhD) in chemistry, biology, or a related field, or
• Doctor of Pharmacy (PharmD), or
• MD or DO or international equivalent
• 5+ years of experience in vendor management and oversight
• 3+ years of product development and/or postmarketing drug experience
• 2+ years of previous functional lead/people management experience

Job Location & Travel

United Therapeutics has the flexibility to hire this role either remotely, or based in our Durham, NC office. This role has a 15% travel expectation to include both international and domestic travel.

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 $163,000 to $185,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.