Valeant Pharmaceuticals

Executive Director, Global Pharmacovigilance & Risk Mgmt (Materiovigilance)

US-NJ-Bridgewater
Job ID
9505
Pos. Category
R&D
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

This position will be responsible for continuous active surveillance of the company's medical device products including, but not limited to, establishing and developing processes for signal detection and management, providing medical input to signal reports and various technical documentation, as well as participating in Global Safety Board activities.

 

This position also provides oversight for the device clinical safety team through involvement and appropriate delegation of activities.

 

Incumbent will lead a team of safety professionals (physicians/healthcare professionals) and will report directly to Head of Global Safety/Risk Management

Responsibilities

  • Global lead for Medical Materiovigilance responsible for marketed device products as well as products in development.
  • Responsible for trending analysis and medical review of aggregate data
  • Contributes to Post Marketing Surveillance plans (PMS), PMS reports, Periodic Safety Update Reports (PSUR), Risk Management Plans, Clinical Evaluation reports in close conjunction with the risk management team members. Provides support for design and conduct of risk management programs.
  • Creation and conduct of risk management strategies research techniques including qualitative and quantitative analyses of pharmacoepidemiology studies (cohort studies, case-control studies, post licensure studies, etc.) to generate data that are important for decision making in each stage of a product's lifecycle.
  • Medical review, reportability assessment of complaint files and MDR/ vigilance reports;
  • Serve as Clinical Expert for product development and design control
  • Serve as medical liaison for NC, CAPA and CAC activities;
  • Prepare and respond to ad-hoc/issues related requests from competent authorities.
  • Perform Health Hazard evaluations (HHE's) and create respective documents in close cooperation with other involved departments.
  • Providing expertise in the design, management and evaluation of study protocols and health status questionnaires, sample selection and analysis; and conducting research to develop methodologies, instrumentation and procedures for analysing data.
  • Develop written reports and procedures Standard Operating Procedures (especially SOP regarding Signal management, Risk Management). 

 

Scope of Position: 

 

Member of the Global Device and Risk Management team, focused on activities related with signal detection, risk assessment and risk management. This position has responsibilities at global level.

 

Direct Reports: Yes

 

Key Relationships:

 

  • Third party provider for PV and Risk Management Activities
  • Other Safety and vigilance contract partners
  • Regulatory Affairs
  • Medical Affairs
  • Quality Department
  • Clinical Development
  • Device Safety Operations

 

 

Qualifications

  • Education: MD or DO Degree
  • Experience: Clinical/patient experience preferred.  Minimum 5 years of experience with medical device safety and at least 5 years management work experience or demonstrated leadership skill
  • Ability to interpret scientific literature; preferably demonstrated through history of authorship in peer-reviewed journals
  • Familiarity with regulatory and product development guidelines governing medical device industry
  • Excellent verbal and written communication skills
  • Ability to learn quickly and work independently in fast-moving environment

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

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