Pharmacovigilance Specialist I

What You'll Do:

This role requires an individual who will be processing adverse event information for spontaneous, solicited, literature and phase IV study cases. Perform Drug safety activities to ensure compliance with Pharmaceutical and Medical device regulations.

This individual is responsible for Post Market and Clinical trial PV Case Processing. This role requires an individual who can perform at a high level in a fast-paced environment and prior safety-related expertise, with an ability to understand and comply with general pharmaceutical industry rules, regulations, and company processes

• Perform tasks and duties in compliance with appropriate SOP, policies, and procedures
• Responsible for Global Pharmacovigilance review of ICSRs in safety database for completeness, accuracy and regulatory reportability.
• Filing of safety related documents and ICSRs.
• Review adverse event data from product complaints, inquiries, and literatures and assess for regulatory reporting requirements.
• Identifies information to be queried and follows up with PV vendor/Medical safety until information is obtained and queries are satisfactorily resolved.
• Collaborate with cross functional development functions - Medical, Clinical Operations, Data Management, Biostatistics, Regulatory, etc.
• Assist Pharmacovigilance department in safety and risk management activities and other relevant safety projects or duties as assigned/needed.
• Ensure that all safety reporting requirements of the FDA and other regulatory agencies are met.
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

How You'll Get There:

• 0-2 years relevant industry experience
• Minimum of 1+ years of direct experience in a drug safety/pharmacovigilance environment within the pharmaceutical industry required.
• Safety Database systems and knowledge of medical terminology required
• Good understanding of Post marketing safety requirements for device/combination products
• Bachelor's Degree in a Life Sciences discipline required; Graduate degree and/or post-doctoral training preferred

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