Medical Safety Manager

Job Title

Job Description

Medical Safety Manager

The Medical Safety Manager is responsible for conducting comprehensive evaluations of safety information sourced form a variety of channels such as Post-Marketing Surveillance (PMS) and literature searches, working under limited supervision.

Your role:

• Provides essential support in bolstering patient safety by actively contributing insights and recommendations to critical processes such as Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit analyses, and recall procedures.
• Offers valuable assistance in delivering safety-related perspectives for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS) efforts, facilitating informed decision-making.
• Collaborates effectively to furnish pertinent safety inputs for regulatory submissions and key documents such as Risk-Benefit Analyses (RBA), protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CERs), ensuring compliance and transparency in safety evaluations.
• Conducts literature reviews and surveillance activities to identify emerging safety issues, ensuring proactive identification and mitigation of potential risks. Provides answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety.
• Contributes to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization. Maintains awareness of evolving regulations and guidelines related to medical product safety and ensures compliance with applicable requirements.
• Provides input into the design and conduct of safety studies and medical device vigilance activities to ensure robust safety surveillance throughout the product lifecycle.
• Analyzes safety data from clinical trials and post-market surveillance to identify potential safety signals and trends, facilitating early detection and intervention for improves patient safety.

You're the right fit if:

• You’ve acquired 5+ years of experience with a bachelor’s degree or 3+ years experience with a master’s degree in areas such as Medical/Clinical Affairs/Medical Safety in the Medical Device industry.
• Your skills include a strong of relevant standards and regulations for the medical device industry (ISO, IEC, etc.). You have strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses and how to conduct them in a medical device environment.

• You have a bachelor’s degree or higher in Medical Science, Nursing or equivalent. Master’s degree or higher preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your clinical expertise and knowledge of standard of care …