Associate Director, Pharmacovigilance Operations (Remote Position)

Location
San Francisco, CA, United States
Posted
May 08, 2021
Ref
1109
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
ASSOCIATE DIRECTOR, PHARMACOVIGILANCE OPERATIONS (Remote Position)

Position Summary:

Global Blood Therapeutics is seeking a leader to carry out Pharmacovigilance operations activities, ensuring compliance with GBT drug products in clinical development and/or post-marketing. The successful candidate will have a strong 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 Associate Director will support the Pharmacovigilance leadership in assigned aspects of Company product programs.

The Associate Director 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)
  • Lead preparation of safety related documents including development of periodic safety reports (DSUR, PADER, PBRER)
  • 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 and/or provide internal and external training on ICSR activities, safety procedures and processes including clinical and post-marketing regulatory reporting requirements
  • Support and/or provide assistance in product filing activities
  • Support Pharmacovigilance leadership in assigned activities and actively participate in daily Pharmacovigilance activities with a" can-do, hands-on, positive attitude"
  • Hire, manage and mentor staff and assign responsibilities to meet timelines within Pharmacovigilance group


Qualifications:

  • RPH , PharmD, RN or 10+ 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
  • Demonstrates leadership and interacts collaboratively and effectively in a team environment (Clinical Operations, Clinical Science, Data Management, Medical Affairs) and external vendors
  • Ability or desire to manage people and teams
  • 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.

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.

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