Job Opportunities

Head of Drug Safety and Pharmacovigilance 

Description

The Head of Drug Safety and Pharmacovigilance, reporting directly to the Chief Medical Officer, is responsible for providing strategic, scientific, and operational leadership and oversight for all Drug Safety/ Pharmacovigilance and Risk Management activities of PMV’s clinical-stage oncology product portfolio.

The Head of Drug Safety and Pharmacovigilance will provide dynamic leadership, strategic direction and governance of patient safety and pharmacovigilance activities, working alongside PMV’s preclinical, clinical and regulatory team members to support the ongoing assessment of safety and the benefit/risk profile of PMV’s investigational products. Key responsibilities include oversight of adverse event evaluation and reporting, oversight of signal detection and risk management activities, participation in strategic program planning, preparation and review of clinical and submission documents, and interactions with clinical investigators, external experts, regulatory agencies, and partner/co-development companies.

This is a hybrid home/office-based position with regular visits to New Jersey HQ (several days per month; up to 1 week per month).

Responsibilities

  • Provide oversight of case processing conducted by the drug safety/pharmacovigilance staff within the CRO(s) responsible for medical evaluation of serious adverse event reports
  • Ensure that adverse event and other safety information is evaluated thoroughly and in a timely manner and is reported in accordance with institutional and local health authority requirements
  • Develop Safety Management Plans and Risk Management Plans related to product safety, ensure ongoing evaluation of the overall safety profiles for investigational products, and ensure that potential safety issues and aggregate data safety signals are identified promptly and communicated appropriately
  • Serve as the product safety expert within the cross-functional development team 
  • Lead Safety Management Team meetings 
  • Participate in the strategic program planning activities within the clinical and development teams
  • Participate in clinical study-level Safety Review Committee meetings
  • Develop/review/approve SOPs related to drug safety/pharmacovigilance activities, and train PMV personnel on SOPs as needed
  • Develop and maintain Reference Safety Information, as appropriate, and communicate identified risks to internal and external stakeholders, as appropriate
  • Provide oversight and assist in the preparation and review of safety sections of clinical documents, including safety portion of protocols, annual reports, final study reports, IBs, ICFs, and other documents, as needed, in accordance with SOPs and Health Authority requirements
  • Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities
  • Participate in the preparation of safety and benefit/risk sections of new license applications and interact with Health Authorities during the assessment

Qualifications

  • Concur experience required
  • At least 8 or more years of business experience in a high-level administrative role is required 
  • Expert skills in Outlook, PowerPoint, Excel, and Word are required
  • Proficiency with productivity tools and portal technology (SharePoint, Datto) is preferred

Requirements

  • MD or DO required; Board Certification in Internal Medicine or related discipline and/or significant patient care experience strongly preferred 
  • Pharmacovigilance experience, including regulatory filing experience, within pharmaceutical industry
  • 7+ years’ relevant pharmaceutical industry experience including experience leading and/or working within a matrix environment
  • Oncology experience preferred
  • Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
  • Excellent communication and analytical skills (written and oral)
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Solid knowledge of US and EU regulations governing drug safety procedures for investigational medicinal products
  • Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient

Benefits

PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.

How to Apply

To apply, please submit your cover letter and resume to Recruiting@pmvpharma.com or apply through our Online Portal.

PLEASE, NO PHONE CALLS or AGENCIES

PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.