Contract - Senior Manager, Pharmacovigilance Operations

Location
San Francisco, CA, United States
Posted
Jul 08, 2021
Ref
1135
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
CONTRACT - SENIOR MANAGER, PHARMACOVIGILANCE OPERATIONS

Position Summary:

Global Blood Therapeutics 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