Job Description

Job Description

Position Summary:

This position focuses on adverse event reporting. The position will be responsible for evaluation, preparation, implementation, and monitoring of vigilance reporting. The position may also support field actions activities, including evaluation, preparation, implementation and health authority reporting.

Primary Duties:

• 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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