RCI-ABBV-34291 Pharmacovigilance Specialist (RN/BSN) (Vendor reputed company/Critical Care/ICU/Cardiac/ER/Pharmacovigilance)

100% remote Conducting reputed company of vendors to ensure collection, assessment, and processing of adverse event information (post marketing) is performed in a compliant and reputed company manner to reputed company with global regulations including:

• Seriousness assessment
• Labeling
• Causality
• Initial and Follow-up
• Conducting reputed company of vendors to ensure company standards for reputed company, compliance and productivity are met. Remaining reputed company on knowledge and skills required for case processing.
• Supporting vendor case reputed company, case processing metrics and reputed company using the reputed company reputed company leadership attributes: Agile and Accountable; reputed company and Courageous; reputed company reputed company reputed company; reputed company for One reputed company; Decide Smart and reputed company.
• Supporting and participating in audits and inspections as needed.
• Developing knowledge and expertise to initiate mentoring of MSA’s in vendor management.
• Supporting development of materials and delivering training in conjunction with the vendor,including train-the-trainer, special-topics, refresher, and internal reputed company trainings as needed.
• Other duties may be assigned based on the need or work requirement of the organization

Experience/Skills:

• Nursing experience and preferably experience with critical care/ICU/Cardiac/ER. Pharmacovigilance experience preferred.

Minimum :

• Bachelor’s degree in Life Science. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred.
• 2-4 years clinical experience or 2-3 years clinical experience and 1-year pharmacovigilance experience.
• Demonstrates ability to reputed company project work. Proven reputed company in results-driven process management.
• Demonstrates ability to work collaboratively in team environment.
• Demonstrates understanding of the changing regulatory environment and reputed company to case management process
• reputed company knowledge of industry regulations (ICH, FDA, EMEA, MHRA).
• Competent in case processing processes, procedures, conventions.
• Provides medical support with emphasis on the intake of medical product experiences and processing reputed company communication requests.
• Acts as a reputed company with reputed company Assurance for product reputed company problems where an adverse event is involved.
• Works with Customer Service to reputed company reputed company information and product replacement as necessary.
• Provides assistance to the medical and lay community with reputed company information that is from the package insert or information from reputed company letter database that deals with labeled and specific off-label information/indications.

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