Valeant Pharmaceuticals Pharmacovigilance Specialist/ Senior Specialist in Bridgewater, New Jersey
Valeant Pharmaceuticals International, Inc. is a diverse 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.
The incumbent will be responsible for post marketing and clinical trial safety activities, ensuring that Adverse Events are identified and processed in accordance with international regulations. The incumbent will also work in close collaboration with Valeant's vendors and affiliates to ensure that individual case reports for pre- and post-marketed products are properly produced, exchanged and submitted.
Provides oversight and support for external safety data processing provider ensuring high quality and compliant individual case safety report processing.
Review and approve adverse event reports for pre- and post-marketed product: clarify medical issues, insure clear narratives, revise MedDRA terms, and coordinate with external vendor and internal medical personnel as needed.
Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed.
Represent the Pharmacovigilance department on clinical project meetings and perform clinical trial support activities relating to drug safety, as required.
Inform Manager/Director of safety related issues and potential trends and or signals arising from review of pre and post marketed safety data.
Knowledge/Skills: Clinical safety and Pharmacovigilance regulations and guidelines, Use of safety database, preferably ARISg; Working knowledge of scientific terms and medical terminology; Excellent oral and written communication skills; Excellent interpersonal skills and willingness to work in a team environment; Demonstrates consistent attention to detail; Highly organized and demonstrates understanding of workflow prioritization.
Education: BS or MS degree in Nursing, Pharmacy or related discipline or comparable field of study from an accredited college or university. Healthcare professional preferred.
Experience: Pharmacovigilance Specialist requires minimum 1-2 year of Pharmacovigilance experience. Sr. Pharmacovigilance Specialist requires minimum of 4 years of Pharmacovigilance experience.
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Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job ID 10212
Pos. Type Full Time