Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products. As appropriate and exceptionally, may be the lead safety support for a compound as the Global Safety Lead (GSL).
Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products
Represent pharmacovigilance, both regionally and globally as an authoritative and knowledgeable member of Global Clinical Development Teams (GCDTs) and similar, commensurate with position s seniority/experience and particularly when the designated GSL.
Closely involved in signal detection/safety monitoring activities for pharmacovigilance operations with a lead responsibility if the designated GSL.
Provide functional & therapeutic area expertise, supporting less experienced colleagues and the safety effort more generally
Flexible outside of primary therapeutic area as directed by business and departmental need.
Technically fully competent to perform all usual Senior Pharmacovigilance 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 PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.
Represent pharmacovigilance 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 PV physicians and the safety Therapeutic Area Lead (TAL), particularly when the responsible GSL.
Provide support and oversight of pharmacovigilance 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:
Bachelor s degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD).
Bachelors with minimum 20 years of experience in healthcare, clinical or pharmacovigilance related environment
Masters with minimum 15 years of experience in healthcare, clinical or pharmacovigilance related environment
PhD with minimum 9 years of experience in healthcare, clinical or pharmacovigilance related environment
Excellent databases and coding skills including ability to perform advanced searches
In depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis.
Critical thinking and decision making skills
Ability to review, analyze, interpret and present complex data to a high standard
Global player in a global PV organization
Excellent communication and presentational skills
Good level of computer literacy
Excellent organization skills and ability to prioritize
Estimated 5-10 times per year including possible international travel.
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