Safety and Security Director
This is what you will do:
The Director, SafetyScientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework You will be responsible for:
Leading risk management evaluation and resolution for assigned products and projects.
Accountability for the following:
Proven skill set for strategic leadership in a cross functional matrix Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications Co-lead activities related to new drug applications and other regulatory filings Represent global patient safety at regulatory inspections i.
e.
MHRA, FDA, EMA, etc.
Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation Leading activities to identify and address process gaps Responsible for vendor management and training including budgets Responsible for overall project distribution across therapeutic area As needed represent GPS in global program teams and associated cross functional teams and/or projects Proactively provide guidance and educational training to GPS therapeutic teams Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration safety physicians.
Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products You will need to have:
Advanced degree in a biologic/medical/clinical/nursing field:
Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry Knowledge and understanding of US and EU safety regulations pre- and post- marketing Experience with Risk Management and Minimization programs Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans Experience with clinical development including risk/benefit analysis and safety assessment Strong clinical, analytical, problem solving and scientific writing and communication skills The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to:
use a computer; engage in communications via phone, video, and electronic messaging;engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Expertise with clinical and safety databases Experience in MedDRA coding and search strategies Excellent, independent judgment based on knowledge and expertise Strong personal time-management and project-management skills Mastery of Microsoft Word, PowerPoint and Excel Recommended Skills Analytical Biotechnology Certified Nurse Practitioner Clinical Development Clinical Works Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
The Director, SafetyScientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework You will be responsible for:
Leading risk management evaluation and resolution for assigned products and projects.
Accountability for the following:
Proven skill set for strategic leadership in a cross functional matrix Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications Co-lead activities related to new drug applications and other regulatory filings Represent global patient safety at regulatory inspections i.
e.
MHRA, FDA, EMA, etc.
Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation Leading activities to identify and address process gaps Responsible for vendor management and training including budgets Responsible for overall project distribution across therapeutic area As needed represent GPS in global program teams and associated cross functional teams and/or projects Proactively provide guidance and educational training to GPS therapeutic teams Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration safety physicians.
Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products You will need to have:
Advanced degree in a biologic/medical/clinical/nursing field:
Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry Knowledge and understanding of US and EU safety regulations pre- and post- marketing Experience with Risk Management and Minimization programs Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans Experience with clinical development including risk/benefit analysis and safety assessment Strong clinical, analytical, problem solving and scientific writing and communication skills The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to:
use a computer; engage in communications via phone, video, and electronic messaging;engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Expertise with clinical and safety databases Experience in MedDRA coding and search strategies Excellent, independent judgment based on knowledge and expertise Strong personal time-management and project-management skills Mastery of Microsoft Word, PowerPoint and Excel Recommended Skills Analytical Biotechnology Certified Nurse Practitioner Clinical Development Clinical Works Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
