- Technically fully competent to perform all usual Senior Patient Safety Scientist workload, including case report QC, review, follow-up and reportability assessments and input into aggregate safety reports, with the flexibility of mindset this requires.
- The attainment of advanced compound expertise might, for exceptional individuals, allow for Global Safety Lead (GSL) responsibilities where the individual has demonstrated both the requisite depth of knowledge and associated advanced communication skills.
- Liaise with other relevant functional areas both within and outside of global GPSE to best ensure the most efficient and timely attainment of compliant and patient focused safety data.
- Represent patient safety department in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.
- In depth knowledge and understanding of designated products/studies. If the responsible GSL, will be seen as the company s lead responder and source of expertise for safety related issues for designated compound.
- Expect close interaction and involvement with senior GPS physicians and the safety Therapeutic Area Lead (TAL), particularly when the responsible GSL.
- Provide support and oversight of patient safety operational activities for designated compounds, with lead responsibilities when acting as the GSL
- Mentorship and guidance for less experienced colleagues within the department.
- Conduct project activities for designated developmental products:
- Lead set up of safety procedures for complex developmental programs
- Contribute to development of safety exchange agreements for co-development projects
- Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
- Close knowledge of protocols to effectively respond to safety issues.
- Providing investigator and monitor training on safety procedures
- Participate in Global Safety Teams, coordinating all aspects of signal detection/safety review activities.
- Draft responses to regulatory/ethics safety questions
- Assist with writing and maintenance of the Safety Monitoring Plan
- Assist with set-up and running of DSMBs
- Close working relationship with physicians, both technically and managerially
- Perform ad hoc analyses e.g. in response to regulatory queries
- Integral to Global Safety Teams and associated support
- Other functions as directed by departmental and business needs
Proficient in all communication skills, with the agility to respond to different audiences in a clear and concise manner. Where acting as the GSL can expect to lead presentations to Safety Board, with the detailed preparatory work this implies and, where ad hoc issues arise, the short timelines that can ensue.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Estimated 5-10 times per year including possible international travel.
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