͏

Responsiblities:

• Ensures, in collaboration with the Medical Safety Officer, processes are in place to guarantee appropriate medical review and input to:

• Risk management report, Safety Surveillance Plans, Post-market surveillance reports, Response to Adverse Event (AE), complaints and mass communications

• Internal and customer safety training materials

• Complaint handling process and reporting decisions. Regulatory reports and filings of product’s harms and hazards list

• Coordinates activities related to trending and escalation in collaboration with the Quality Unit and the Medical safety Officer:

• Coordinates completions of the Health Hazard Evaluation including routing documents to MSO, review of appropriateness of data available, tracking of timeliness and routing for approval.

• Review of periodic surveillance data to identify any significant triggers and provide an analysis of the triggered events to identify any safety concerns. Participate in periodic trending meeting and provide input on actions taken for identified signals.

• Complete Analysis of identified trends and make recommendations for further escalation when appropriate.

• Coordinate completion of Health Risk Assessment for Product Issue Escalation and participate, in collaboration with the Medical Safety Officer, in multidisciplinary team discussions by providing surveillance data analysis and severity assessment per risk management documentation.

• Coordinates and completes activities related to Product development and risk management in collaboration with New Product Development teams and the MSO:

• Represent Medical Safety interests in multi-disciplinary teams during product development.

• Perform clinical reviews and provide input of clinically related product risk issues during the development of the clinical portion of risk management documents such as FMEA’s, Risk Management Plan, Risk Management Report and Post-market Surveillance reports in support of new product development and regulatory requirements.

• Evaluation and review of non-Clinical contributions to risk management documents such as FMEA’s, Risk Management Plans, Risk Management Reports, Post-market Surveillance reports and Health Hazard Evaluations for conformance to procedure, completeness, content and accuracy.

• Coordinates and completes activities related to support of the Complaint Handling process in collaboration with the Complaint Handling Unit and the MSO:

• Provide guidance to complaint handling specialist regarding investigation of product related events reported worldwide from patients, customers, sales reps and clinical studies/registries in order to assess product relationship to reported complaint.

• Provide clinical guidance and validates correct coding and regulatory reporting of complaint files.

͏

Qualifications:

• Bachelor's Degree graduate of any Allied Health Professionals with licenses.

• At least 3 to 5 years of experience in clinical research, pharmacovigilance, and surgical background and/or equivalent is required.

• At least to 3 to 5 years of experience in the pharmaceutical, medical device industry or direct device clinical experience preferred. 

• Regulatory Affairs/ Quality Assurance or complaint handling experience in pharmaceuticals or medical devices preferred.

• Understanding of risk assessment principles preferred

• Experience interacting with the FDA and/or other regulatory agencies preferred

• Excellent communications and analytical skills

• Working knowledge of Microsoft Office, Excel, Power Point, Access