Job Description
The Safety Manager, champions product safety through involvement in post-market surveillance, risk management, clinical support and education.
PRINCIPLE RESPONSIBILITIES:
- Maintains thorough knowledge of the science of device in order to be an educated resource in products and treatment innovations in the health care industry. Advise Global team members regarding questions and issues with therapies, product knowledge, and product development.
- Develops risk assessments for innovation projects, including risk benefit analysis, residual risk, safety review of post marketing data and literature reviews.
- Contributes to the update and development of clinical guidelines for company’s products.
- Actively participates in Health Hazard Assessment/Evaluationsand Corrective Actions related to marketed products.
- Collaborates in the post marketing surveillance activities providing/ supervising clinical review of safety data for products.
- Provides authorship to the risk/benefit analysis of products as required
- Conducts reviews of safety information as needed and contribute to the content of the product labeling by incorporating product safety knowledge (gained through interactions with the product users).
- Supports Company internal training, the Training and Education Center, and Sales and Marketing groups by providing clinical expertise, knowledge and experience on all products.
- Responds to safety, clinical and usage queries received from internal and external customers via clinical calls or emails
- Reviews accuracy of the clinical and safety content of literature , including communications to internal and external customers, regarding therapies, product evaluation and data conclusions.
- Collaborates with other groups in the Medical division, Marketing, Regulatory Affairs, Research & Development, Legal, labeling and Quality Assurance on various projects.