The Manager will be integral in the day-to-day functioning of the Pharmacovigilance team. The incumbent will contribute to a full range of Pharmacovigilance activities including vendor management, operations, and compliance. In addition, he/she will also function in a company matrix environment with several key groups including Biometrics, Clinical Operations, Clinical Science, Quality Assurance, and Regulatory Affairs.
Essential Duties and Responsibilities:
Ensure all safety reports are triaged, processed, reviewed and submitted accordingly per global regulatory requirements and Global Blood Therapeutics (GBT) standard operating procedures
Manage and provide oversight for day-to-day interaction with Pharmacovigilance vendor(s)
Track ICSR to completion and adherence to processing timelines
Represent Pharmacovigilance in study execution teams for assigned studies
Assist with the development and implementation of Safety Management Plans between GBT and Pharmacovigilance vendor(s)
Oversee reconciliation of safety data with external teams (Safety vendor, Data Management)
Maintain well organized, auditable regulatory files
Qualifications:
Health care professional (RN, Pharm.D., MD, or equivalent) with, at minimum, 3 years clinical experience or 6+ year of global Drug Safety/Pharmacovigilance experience in pharmaceutical industry
Excellent knowledge of FDA, EU and ICH guidelines and regulations governing clinical trials and post-marketing safety
Proven ability to manage Pharmacovigilance vendor(s)
Knowledge of medical terminology and general principles of adverse event clinical assessment
Knowledge of MedDRA dictionary relevant to adverse event and serious adverse event coding
Experience with software-based drug safety systems (ARISg a plus, ARGUS, or equivalent)
Experience with clinical databases (InForm, eCOS, or equivalent)
Excellent communication and interpersonal skills, including ability to work cross-functionally and cross-culturally
Excellent written and spoken English
Ability to listen and think critically (sometime creatively)
Experience in public speaking, a plus
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
Flexibility
Integrity
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.
Internal Number: 704
About Global Blood Therapeutics
About Global Blood Therapeutics
GBT is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta™ (voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of SCD. GBT is also advancing its pipeline program in SCD with inclacumab, a p-selectin inhibitor in development to address pain crises associated with the disease. In addition, GBT’s drug discovery teams are working on new targets to develop the next generation of treatments for SCD. To learn more, please visit www.gbt.com and follow the company on Twitter @GBT_news.
