Post Market Surveillance Specialist
The Judge Group Inc.

Location: Crystal Lake, IL
Description: Our client is currently seeking a Post Market Surveillance Specialist for a 10 months + contract.

Key Areas of Responsibility: Facilitate product complaint process by performing safety review to determine seriousness and event resolution. Prepare and submit expedited drug and medical device reports to US and International regulatory agencies within required timeframe. Prepare Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update reports (PSUR) for drug products. Engage external customers in verbal or written communication regarding complaints and/or inquiries. Respond to customer with investigation findings as requested. Review and approve customer quality complaint investigations. Engage internal customers in written and verbal communication concerning internal procedures and regulatory requirements related to complaint handling systems and regulatory reporting. Facilitate training on product complaint and adverse event reporting requirements. Support Post Market Surveillance for EU Medical Devices. Prepare and review PMCF plans and reports and PSURs. Conduct PMCF Surveys and present findings to Management Review. Conduct and review clinical evaluations on EU marketed Medical Devices. Monitor and present on monthly quality metrics related to adverse event reporting. Participate in audits, acting as a subject matter expert for customer complaints, adverse event reporting, and clinical evaluations. Other responsibilities as assigned.

Education / Work Experience: Bachelors degree, Nursing or other Qualified Health Professional. 2+ years experience working in a clinical setting. Experience working in Post Market/Regulatory Affairs/Clinical Affairs.

Knowledge / Competencies: Clinically skilled, licensed health care professional Pharmacovigilance and device vigilance experience preferred Complaint handling experience Must possess excellent oral and written communication skills Possess attention to detail Must be highly customer-service oriented Strong product knowledge preferred. Knowledge of FDA/EU MDR/International guidelines for drug/device safety reporting requirements Job Description Summary: Develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.

Contact: eronan@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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