Product Safety Senior Medical Scientist - Remote Position
PRODUCT SAFETY SENIOR MEDICAL SCIENTIST - REMOTE POSITION
Global Blood Therapeutics is seeking a leader to carry out safety risk management functions for GBT investigational and marketed products. The Product Safety Medical Scientist will support members of GBT Pharmacovigilance Product Safety Teams, including the Product Safety Officer and Product Safety Scientist in carrying out critical pharmacovigilance activities such as signal detection/management, risk management activities, and overall benefit-risk management of assigned products. The Product Safety Senior Medical Scientist will report to the Vice President of Pharmacovigilance & Risk Management.
Essential Duties and Responsibilities:
- Under the oversight of either the Vice President Pharmacovigilance & Risk Management or Product Safety Officer, the Product Safety Senior Medical Scientist will participate in implementing the approved signal detection strategies for assigned molecules including signal detection, signal analysis, validation, prioritization, and development of safety communications.
- Work with the Product Safety Officer and Product Safety Scientist to prepare presentations for the Safety Analysis Team (SAT), Cross-Functional Safety Teams (CFST), and when applicable the Drug Executive Safety Committee (DESC) on safety issues.
- Assist the Product Safety Officer in creating Risk Management Plans to ensure the safe and appropriate use of GBT products in compliance with global regulatory requirements. As well as, participate in the implementation of appropriate risk minimization activities, and work with cross-functional GBT staff to carry out effectiveness checks of risk minimization activities.
- Work with the Product Safety Officer and EU QPPV to review Post Authorization Safety Studies.
- Work with Product Safety Officer and Product Safety Scientist to author safety assessment reports for identified safety signals, as well as provide input into aggregate reports such as the PADERs, DSURS, PBRERS,
- Assist the Product Safety Officer in providing safety oversight of clinical trials including reviewing and providing input to study protocols, statistical analysis plans, the Risk Discomfort Sections of the ICF, safety sections of the IB, attendance (if required) at study execution teams, clinical study teams, and safety committees. In addition, under the direction of the Product Safety Officer, review tables, listings, figures, and other safety data to support filing for new drug products as well as supplemental filings.
- Work with the Product Officer and Product Safety Scientist in creating safety content for labelling documents (e.g. Core Data Sheet, and local labels).
- Effectively lead Pharmacovigilance communications with senior management and governance committees, as applicable (e.g. Senior Management Team, Product Development Team).
- Work with the Product Safety Officer in responding back to health authority requests, and participate in other health authority interactions, such as advisory boards or scientific advice meetings.
- Ensure compliance with global AE/SAE reporting requirements for all post-marketed products and products in development programs
- Support Pharmacovigilance leadership in assigned activities and actively participate in daily Pharmacovigilance activities with a “can-do, hands-on, positive attitude”
- Other duties, as assigned
- MD (or equivalent) with 7 years clinical experience in either an accredited academic setting or private practice including a hospital setting
- Clinical/medical research experience
- Excellent command of English (both written and spoken)
- Ability to navigate fast paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must
- GBT values driven leader: Science dedicated to patients; Embrace open communication and debate; Trust, respect, and accountability; One team, one purpose; and always do the right thing
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.