Senior Manager, Pharmacovigilance

 

Improving quality-of-life through innovations in urology.

Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions and improving the way providers and their patients confront urologic diseases that are difficult to treat.

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist is being evaluated for overactive bladder (OAB).  In December 2019, the Company submitted a New Drug Application to the FDA seeking approval of vibegron for the treatment of patients with OAB.  Vibegron is also being evaluated for treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH) and for abdominal pain associated with irritable bowel syndrome (IBS).

Urovant’s second investigational product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.

 

Position Description: 

Urovant Sciences is currently seeking a Senior Manager, Pharmacovigilance responsible for contributing to the Pharmacovigilance function at Urovant and working closely with the Executive Director of Pharmacovigilance.

Primary Responsibilities:

  • Support the Pharmacovigilance function and work with the Executive Director Pharmacovigilance, the Clinical Development Team Leaders, the responsible Medical Monitors of the Clinical contract research organizations, the product call center, and the Pharmacovigilance vendors of all clinical trials at Urovant.
  • Work with the Executive Director for Pharmacovigilance on all post-marketing activities including safety operations and case processing, safety surveillance, signal detection, and benefit-risk assessment, in collaboration with selected Pharmacovigilance vendors.
  • Review of safety sections of INDs, IMPDs or other regulatory documents, safety aspects and modules of the CTD, the draft regulatory labels, the periodic regulatory safety reports, safety sections in the Investigator Brochures, the Informed Consents, clinical study protocols and clinical study reports.
  • Involvement in oversight of the Pharmacovigilance vendors, including the vendors for the Global Safety databases, and safety consultants.
  • Collaboration with Data Safety Monitoring Boards for clinical trials together with the Executive Director Pharmacovigilance, the Clinical Development Team Leaders, and clinical teams.
  • In collaboration with the Executive Director Pharmacovigilance, support Pharmacovigilance process development, workflow efficiencies, quality improvement, and inspection readiness
  • Working closely with the Executive Director Pharmacovigilance on resourcing and budgets regarding the Pharmacovigilance function and vendors.

 

Education and Experience: 

  • Bachelor’s Degree required.
  • Healthcare or clinical training (RN, RPH, PhD, PharmD, MD, DO) or other relevant graduate degree) desirable. Is this correct?
  • 7 plus years of experience working in safety departments in pharmaceutical development.
  • Knowledge of FDA regulations, ICH guidance, GVP and GCP regulations.
  • Knowledge of drug development, post-marketing, and interdependencies with the overall development process.

 

Essential Skills and Abilities:  

  • Proven ability to work with a high level of integrity, accuracy, and attention to detail.
  • Strong technical and analytical skills to identify and solve problems.
  • Proficient organizational skills with the ability to manage multiple complex projects/tasks at the same time.
  • Excellent written and oral communication skills.
  • Knowledge of MedDRA and Argus or similar applications and systems.
  • Ability to prioritize tasks and work across locations and time zones.
  • A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect.