[Remote] Senior Global PV Compliance Manager & Deputy EU/UK QPPV (m/f/d) at Vontive

Germany

Vontive Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Pharmaceuticals, BiotechnologyIndustries

Requirements

  • Bachelor’s degree minimum in a medical or scientific field
  • Proven experience in Global Pharmacovigilance, specifically compliance, working in a global-regional-local patient safety model where two-way direct communication has been required to ensure functional alignment globally
  • Excellent leadership and interpersonal skills demonstrated through successfully leading and driving PV audits and inspection processes, in particular Regulatory Authority Inspections (i.e., EMA, MHRA, FDA, Chinese HA, PMDA and TGA)
  • Successfully demonstrated people management experience as well as ability to manage a close team of experts

Responsibilities

  • Acts as the contact person for the Competent Authorities for medical safety requests/questions regarding a medicinal product licensed in the EU/UK in the absence of the QPPV
  • Together with QPPV acts as a single contact point for the Competent Authorities on a 24-hour basis
  • Overviews safety profiles, knowledge of any emerging safety concerns and any other information relating to evaluation of the risk-benefits of the medicinal products for which Vantive holds authorizations in the EU/UK
  • Maintaining access to a medical doctor for the assessment of medical emergencies, case evaluations, safety signal proportionality or benefit-risk assessments
  • Review and support PV benefit-risk content sections of drug therapeutic product labeling
  • Lead preparation and conduct of PV audits and inspections, ensuring that all stakeholders are properly trained in compliance and inspection readiness needs
  • Responsible for managing and facilitating audits and inspections, providing adequate CAPA handling of the observations available in audit reports
  • Accountable for the proper management of GPS QMS documents and has oversight responsibility for GPS Pharmacovigilance global processes
  • Manages the GPS training process
  • Supervises and manages the GPS global PV agreement process
  • Supporting the development and maintenance of GPS Quality Management System, with oversight of GPS training strategy
  • Leading and facilitating GvP audit and inspection activities, as well as supporting management of GPS global PV agreements
  • Serving as the Deputy Qualified Person for Pharmacovigilance for the European Union (EU QPPV) and UK QPPV working closely with the EU/UK QPPV

Skills

Pharmacovigilance
PV Compliance
QPPV
Quality Management System
GvP
Audits
Inspections
GPS Training
Benefit Risk Management
Regulatory Compliance

Vontive

Provides investment property mortgage solutions

About Vontive

Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.

San Francisco, CaliforniaHeadquarters
2017Year Founded
$32.1MTotal Funding
DEBTCompany Stage
Financial Services, Real EstateIndustries
11-50Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Unlimited Paid Time Off
Parental Leave
Short- and Long-term Disability Coverage
Life Insurance
Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.
Potential regulatory scrutiny may lead to higher compliance costs and challenges.
Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.
The platform integrates financial institutions through a unique debt marketplace.
Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.
The company has financed over $1.1 billion in residential properties since April 2022.
Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

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