Manager, Pharmacovigilance

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.