Head of Pharmacovigilance Device, Product Quality& Consumer Safety

Whippany, NJ, United States
Jun 09, 2018
Required Education
Position Type
Full time
Your tasks and responsibilities

The primary responsibilities of this role, Head of Pharmacovigilance Device, Product Quality& Consumer Safety, are to:

  • Lead the Pharmacovigilance (PV) Device Vigilance and Risk Management Consumer Care function for Bayer including all associated quality, training, and compliance activities;
  • Manage all strategic, organizational, and administrative activities required for successful operation of the function across multiple sites and diverse cultures;
  • Drive the definition of Risk Management and Device Vigilance strategies; establish operational goals in line with strategies, monitor progress against them, and hold direct reports accountable for their roles in achieving them;
  • Proactively identify business drivers and changes, and incorporate into processes and plans such as global regulatory changes, new product launches, and new partner arrangements;
  • Drive overall prioritization of Drug Safety objectives and initiatives and resolve conflicting priorities;
  • Form, lead, and motivate a team of PV experts and support functions from diverse cultural and medical backgrounds located at various global sites to ensure patient safety of Consumer Care products and Medical Devices, maintaining compliance with Pharmacovigilance and device vigilance regulations of competent authorities around the globe through the effective and timely completion of all Safety Surveillance and Risk Management requirements;
  • Assure audit preparedness; review function performance in reference to defined targets and KPIs and take preventative or corrective actions, as necessary;
  • Direct, manage and improve the Device Vigilance and Risk Management function for Consumer Care products and Devices through all related processes: risk management planning, ongoing benefit-risk monitoring, signal detection and management, and aggregate reporting and Device Reporting;
  • Provides guidance and participates in governance procedures to protect patients, healthcare providers, and Bayer with over 600 products and 100 Devices across a broad spectrum of drug and device classes and indications;
  • Achieve agreed productivity levels; generate and implement continuous process improvements to drive quality and efficiency. Contribute to the resource planning and manage the workload balancing between the sites and groups to achieve these goals;
  • Oversee the provision of critical infrastructure including: Fiscal control, Analysis of compliance and metrics, quality assurance, training and knowledge management, identify improvement opportunities, lead strategic initiatives and provides resources to manage implementation.

Who you are

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • Medical Doctor degree required, with long-term Pharmacovigilance experience and at least first clinical experience;
  • Extensive knowledge of Pharmacovigilance processes and local and global regulatory rules and regulations;
  • Comprehensive knowledge of EU PV Legislation and Good Pharmacovigilance Practice;
  • Extensive knowledge on Safety Risk Management Processes and principles of Safety Aggregate Reporting;
  • Excellent understanding regarding principles of Serious Adverse Event (SAE)/Adverse Event (AE) and Device Vigilance reporting;
  • Diversified knowledge of in-depth safety policies and procedures in major countries;
  • Well-developed analytical thinking combined with high sense of responsibility and accountability;
  • Fluent English.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country: United States
Location: NJ-Whippany