Associate Director, Safety Scientist job in Cranbury
|Employer:|| Amicus Therapeutics|
|State:||New Jersey (NJ)|
Associate Director, Safety Scientist
The Associate Director, Safety Scientist plays a pivotal role within Global Drug Safety to ensure safety assessment for all Amicus products, in close collaboration with the product assigned Global Safety Leads. The Scientist is responsible for aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements, as well as safety surveillance and risk management activities pertaining to Amicus products.
- Creation, coordination, preparation, and completion of aggregate safety reports for Amicus products (e.g.PSUR, PBRER, PADER) for submission to regulatory agencies around the world, as well as internal safety surveillance documents/'white papers'
- Handling internal ad hoc queries/reports, analyzing/summarizing safety data from various sources, and management of signal detection activities
- Development and management Risk Management and Pharmacovigilance Plans and risk management activities for Amicus products, including the management of the operations of benefit risk committee and resulting action plans
Roles and Responsibilities
The Associate Director, Safety Scientist is responsible for:
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas
- Assists Global Safety Physicians in developing a strategy for safety-related regulatory activities
- Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians .
- Authors high quality aggregate safety reports to meet regulatory and internal deadlines; ensures all safety regulatory documents are processed and submitted according to regulatory requirements
- Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control
- Performs routine signal detection & discusses the results with safety physician for assigned products and ensures adequate documentation and tracking of the analysis results.
- Prepares presentation for the Global Safety Management Team's recommendations on safety issues to the cross-functional decision-making bodies
- Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products
- Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off
- Develops or updates strategy and content for regional risk management plans, in collaboration with local safety officer
- Assists Safety Physicians to oversee risk minimization activities including tracking of activities as needed
- Assists in the evaluation of risk minimization activity
- Assist with responses to regulatory inquiries related to risk management plans under the guidance of global safety physicians
- Supports activities related to new drug applications and other regulatory filings
- Contribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templates
- Participate in other teams and committees as assigned