1 Dec 2022
Full-Time Safety Scientist Manager
Job Description
Job Description
The MSSc supervises the SScs and fosters a positive work atmosphere through frequent communication with the SScs as well as with the Global Safety Leads
The MSSc monitors the work outcome from SScs with regards to timeliness and quality aspects and ensures that activities are properly documented and workload evenly distributed. The MSSc acts as a mentor for the SScs
Acting also as a SSc the MSSc is also responsible for the following
- Monitoring the safety profile of one or more products
- Performing routine signal detection activities
- Managing cross-functional signal validation projects
- Obtaining cross-functional input for signal validation reports and writing of such reports in close cooperation with the Global Safety Lead
- Managing SMT meetings from scheduling to minuting including presentation of pharmacovigilance data at such meetings
- Conducting ad hoc safety analyses, e.g., for health authority requests or other regulatory projects
- Documentation of performed activities
- Providing input to Mallinckrodt procedures
- Work in conjunction and effectively communicate with Product Monitoring, Medical Information, Regulatory Affairs (RA), International RA, Clinical Operations, Sales, Legal, Marketing, Quality Assurance, and other department personnel.
- Participate in team activities regarding the safety, development, or support of products as necessary.
- Attend seminars to stay current with relevant global regulatory requirements and guidance regarding drug safety and pharmacovigilance.
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