Postmarket Surveillance Specialist II

Position Summary:

• Support vigilance and field action processes by collecting, documenting, and organizing incident data under close supervision.
• Collect and consolidate data for post-market surveillance Quality (Vigilance , FA  , PMS) reports or periodic safety update reports (PSUR) .
• Regularly collect and consolidate vigilance and PMS key performance indicators (KPIs), follow up on action plans related to these KPIs with quality management representatives (QMR).• Monitor open non-conformities for late reports or incorrect classification of potentially reportable events (PRE) from technical complaints.• Support the monitoring of actions associated with CAPA or audit/inspection findings.• Support internal preparation for internal/external audits or inspections related to vigilance activities or field actions.• Assist vigilance and PMS teams with changes/updates to tools (e.g., TrackWise Digital by writing and executing test cases, ISOTOPE).
• Reviews and assesses new PRE customer complaints
• Completes global and local PRE assessments and weekly checks for reportability in a timely manner according to regulations 
• Performs other duties such as reading regulations, audit preparation, and other assigned projects 

Training and Education:
Required Bachelor's degree in related field (Biology, Anthropology, Microbiology, Chemistry, Ecology)

Experience:

Preferred 3 years professional experience in field in a scientific background (microbiology, lab testing, etc.) or in regulatory affairs (postmarket surveillance, adverse event reporting, etc.)

Knowledge, Skills, Abilities:

• Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment.
• Leading without authority through influence and guidance of others towards a common goal by using expertise, persuasion, and personal qualities to inspire action.
• Critical thinking, adaptability, time management, communication, problem-solving and digital literacy.

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