Valeant Pharmaceuticals Pharmacovigilance Specialist / Sr. Specialist in Bridgewater, New Jersey
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 case 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. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet
Job ID 9328
Pos. Type Full Time