Valeant Pharmaceuticals

Senior Materiovigilance Specialist

US-NJ-Bridgewater
Job ID
9636
Category
Quality
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.

 

  • Lead in the development and update of departmental procedural documents, to assist in the development of training materials and curriculum for GDCM (Global Device Compliance Management).
  • Contribute to the GDCM globalisation and EU-MDR (medical device regulation) implementation activities as assigned. 
  • Responsible for preparation of SOPs ensuring internal and external compliance with all company SOPs, Competent Authority laws and guidelines in the development of departmental SOPs.

Responsibilities

  • Act as lead in the global development of departmental procedural documents (SOPs, WI) including but limited to initiating the document change request process for new/updated departmental procedures and processes.
  • Liaises with internal functions (Quality, Regulatory, Medical Affairs, Clinical ) to gather critical input into procedural documents.
  • Contribute and participate in assigned activities associated with the company implementation of the EU-MDR.
  • Strong skills in working and leading change within a global team.
  • Develop and maintain an understanding and competence in all company SOPs, ANZ regulations and Local Laws, GCP, ICH as well as ethical standards ensuring alignment with global requirements.
  • To represent GDCM and the company in an ethical and positive manner
  • No direct reports 

Key Relationships: 

  • Internal: Regulatory Affairs, Customer Service, Medical Affairs & Clinical Operations, Quality Assurance
  • External: Local Regulatory Agency, Company Service Providers

Qualifications

  • Degree in Medical or Life Sciences, Nursing or Pharmacy, with experience in a specific therapy area or with a broad medical/clinical background.
  • At least 5-8 years of pharmacovigilance and/or materiovigilance experience/Post Marketing Surveillance (PMS) or related area in the pharmaceutical industry or medical environment
  • Familiarity with industry principles and regulations of vigilance and clinical safety
  • Experience in development and implementation of company Standard Operating Procedures
  • Strong organisational skills, detail orientated, ability to adapt in a fast paced constantly changing environment
  • Ability to work independently and within a Global Team
  • High level of computer proficiency (Microsoft Word, Excel, PowerPoint and Outlook)
  • Clear, effective written and verbal communication skills
  • Good interpersonal and leadership skills (i.e., team player)
  • Travel (when required)~10 %

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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