Skip to main content
McCarthy Search

VP, PV and Drug Safety

L7

hlx life sciencesBrooklyn, NYyesterday

Occupations

Regulatory Affairs ManagersNatural Sciences ManagersCompliance Managers

Industries

Pharmaceutical Preparation ManufacturingBiological Product ManufacturingResearch and Development in Biotechnology
Our client is a clinical-stage biotechnology company based in New York, focused on developing new therapies for neurological disorders. The company has a strong scientific foundation and a growing clinical pipeline, and it is building out its leadership team for the next stage of development. They are now looking for a Vice President, Pharmacovigilance & Drug Safety to lead the company’s safety function and make sure patient safety is built into every stage of development.
The Opportunity: As VP, Pharmacovigilance & Drug Safety, you will be the company’s senior safety leader. You will own the strategy, systems and processes that monitor and manage the safety profile of its investigational products. This is a hands-on leadership role: you will build and scale the function, work closely with the executive team, and serve as a key voice with regulators, investigators and partners.
Key Responsibilities:
  • Set and lead the pharmacovigilance and drug safety strategy across all clinical programs
  • Build, lead and develop the safety team, and manage relationships with PV vendors and CROsOversee case processing, medical review and expedited reporting of serious adverse events in line with global regulatory requirements
  • Lead signal detection, evaluation and risk management activities, including benefit-risk assessments
  • Own aggregate safety reporting, including DSURs and IND safety reports, and contribute safety content to INDs, CTAs, IBs, protocols and CSRsChair or lead internal safety review committees, and support Data Monitoring Committees
  • Make sure safety databases, SOPs and processes are fit for purpose and inspection-ready
  • Act as the safety lead in interactions with the FDA and other health authorities
  • Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics and Medical Affairs on study design and safety monitoring plans
  • Prepare the safety function for later-stage development and future marketing applications
Qualifications:
  • PharmD, PhD or other advanced degree in a relevant life sciences discipline
  • Extensive pharmacovigilance and drug safety experience in biotech or pharma (typically 12+ years), including senior leadership of a safety function
  • Strong knowledge of global PV regulations and guidance (FDA, EMA, ICH E2A–E2F, GVP)
  • Hands-on experience with signal management, aggregate reporting and risk management planning
  • Proven track record leading health authority interactions and supporting regulatory inspections or audits
  • Experience overseeing safety vendors, CROs and safety databases (e.g. Argus, ArisGlobal)
  • Excellent leadership, communication and cross-functional influencing skills
  • PreferredSafety experience in neurology or CNS programs
  • Experience across early- and late-stage development, including NDA/BLA or MAA submissions
  • Experience building or scaling a safety function in a growing biotech
  • What’s on OfferAn executive-level role with real ownership of a critical function
  • The chance to shape safety strategy for a promising neurology pipeline
  • Competitive base salary, annual bonus and equity
  • Comprehensive benefits package
  • Hybrid working from the company’s New York office
This search is being managed by Hlx Life Sciences on behalf of our client. All applications and enquiries will be handled in confidence.
Apply now (opens in a new tab)
Apply now (opens in a new tab)

Level

ManagerL7

Location

Brooklyn, NY

Occupation

Regulatory Affairs Managers

Industry

Pharmaceutical Preparation Manufacturing

Posted

yesterday

To get sharper similar jobs, create your profile using the link below.

Create profile