Job Description
One of our large Life Sciences clients in NJ is looking for a pharmacovigilance specialist to join their team for a 6-month contract. This individual will be responsible for assisting the Pharmacovigilance Manager in the oversite of all pharmacovigilance activities performed internally at the client, and / or by external vendors. The Pharmacovigilance Specialist will collaborate with a multidisciplinary team including but not limited to external vendors, Quality Assurance, Regulatory Affairs, Medical Affairs, and Production / Operations to ensure compliance with current FDA regulations and the regulations of other governing bodies. This person will be responsible for staying up to date with current FDA regulations, ICH guidance, and the guidance of other regulatory governing bodies regarding Pharmacovigilance. They will write and review Corporate Pharmacovigilance Standard Operating Procedures (SOPs),
analyze and monitor all serious, non-serious, listed, and unlisted cases for accuracy, consistency, and compliance with all regulatory requirements, review and approve device malfunction reports for a drug-led combination products, ensure all necessary follow-ups are performed for all cases through case completion, and assist in the review of aggregate reports and other regulatory documents as needed to the required deadlines.
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Required Skills & Experience
•5+ years of experience within the pharmaceutical or healthcare industries
•3-5 years of pharmacovigilance/drug safety related experience
•Must have knowledge of current FDA regulations and guidance, ICH guidance, and the regulations and guidance of other regulatory agencies regarding pharmacovigilance and medication safety
•Ability to work with a multidisciplinary team and establish working relationships both internally and externally
•Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint
•Experience in the use of the Argus Safety Database
•Working knowledge of MedDRA
•Ability to read, understand, and write highly technical material
•BS Degree in a health or science related field
Nice to Have Skills & Experience
•Fluency in Spanish is a plus
•Experience in Women's Health
•Experience with Case Explorer
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.