Contract - Senior Manager, Pharmacovigilance Operations

CONTRACT - SENIOR MANAGER, PHARMACOVIGILANCE OPERATIONS

Position Summary:

Global Blood Therapeutics, Inc. (GBT) is seeking a Senior Manager to support Pharmacovigilance operations activities, ensuring compliance with GBT drug products in clinical development and/or post marketing. The successful candidate will have a good Pharmacovigilance operations and compliance knowledge including experience with global individual case safety report handling and management of external Pharmacovigilance service provider(s) to ensure company business needs are met. The Senior Manager will support the Pharmacovigilance leadership in assigned aspects of Company product programs.

The Senior Manager will report directly to the Senior Director, Business, Strategy and Compliance, Pharmacovigilance & Risk Management.

Essential Duties and Responsibilities:

• Serves as primary day-to-day resource and contact for other functions within GBT for Pharmacovigilance operational activities
• Ensure compliance with global AE/SAE reporting requirements for all post-marketed products and products in development programs
• Provide and communicate regularly with Pharmacovigilance provider and develop quality ICSR case processing reporting metrics (includes monitoring of key performance indicators and quality metrics of PV staff in regard to outsourced PV activities)
• Organize and record management of PV documentation and procedural documents (eg. Safety Management Plans, PV Agreements) to ensure inspection readiness
• Assist in management of company and Pharmacovigilance inspections
• Perform reconciliation of AEs/SAEs and/or contribute to solving reconciliation issues and discrepancies
• Support Pharmacovigilance leadership in assigned activities and actively participate in daily Pharmacovigilance activities with a “can-do, hands-on, positive attitude”

Qualifications:

• RPH, PharmD, RN or 6-9 years of relevant global Pharmacovigilance experience/expertise, with experience in operational and compliance position
• Demonstrated knowledge of relevant FDA, EMA, and ICH guidelines, initiatives, and regulations governing both clinical trial and post-marketing safety environments
• 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
• Knowledge of MedDRA dictionary with relevance to adverse event coding
• Interacts collaboratively and effectively in a team environment (Clinical Operations, Clinical Science, Data Management, Medical Affairs) and external vendors
• Experience providing guidance to team member(s)
• 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
• 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.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.