Valeant Pharmaceuticals

Director, Global Pharmacovigilance & Risk Management (SDEA)

US-NJ-Bridgewater
Job ID
9551
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 assume responsibility for the preparation and maintenance and tracking of Safety Data Exchange Agreements (SDEAs).

 

This position will responsible for the coordination of SDEAs in all regions globally. It will have 4 Direct Reports in various regions globally.

Responsibilities

  • Manages the global SDEA Team
  • Manages all SDEA functions in all regions globally
  • Communicates the pharmacovigilance impact in business agreements with Business Development and other Local parties (i.e., GM) responsible for the creation of business agreements
  • Trains/educates Business  Development and other Local parties (i.e., GM) responsible for the creation of business agreements regarding notifications to SDEA Team, involvement of GPRM in business agreements, and impact to GPRM
  • Provides training and guidance to SDEA team
  • Provide process improvements to SDEA team and relevant GPRM team members and/or external Departments with regard to the SDEA function
  • Manages activities related to the SDEA GSOP, GREF's, GTEM's, etc.
  • Acts as contact point for business partners, other departments, third party provider(s) and authorities regarding SDEAs
  • Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines. Develops, communicates, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
  • Direct reporting to Global Head of Pharmacovigilance Operations
  • Dotted line reporting to EU QPPV

Key Relationships: 

  • Third Party provider(s)
  • Business partners
  • Regulatory Affairs
  • Other Third Parties
  • Quality Department
  • Local/Regional Responsible Persons for Pharmacovigilance
  • Medical Affairs
  • Clinical Operations
  • Business Development

 

Qualifications

  • Pharmacist of Health Science Degree preferred. 
  • At least 5 years of experience in Pharmacovigilance required.
  • Experience in SDEAs preparation required.
  • Strong organizational skills, detail-oriented, ability to adapt to a fast-paced and changing environment
  • Proven written and oral communication skills in English
  • Ability to work under pressure to meet tight deadlines

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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