Medical Director, Pharmacovigilance

San Francisco, CA, United States
Sep 04, 2019
Biotech Bay
Required Education
Position Type
Full time

Position Summary:

Global Blood Therapeutics is seeking a leader to carry out pharmacovigilance and risk management functions for GBT investigational and marketed products. The successful candidate will ensure proactive and timely risk-benefit assessment of safety data to characterize emerging and known safety profiles of all GBT products. The Medical Director will ensure successful implementation, execution, and maintenance of safety-related strategies, processes and systems that adheres to Pharmacovigilance standards and compliance with global regulations. The Medical Director will support the Pharmacovigilance leadership in assigned aspects of Company product programs.

The Medical Director will report directly to the Senior Director, Pharmacovigilance.

Essential Duties and Responsibilities:
  • Perform individual case safety report assessments for reported clinical trial and post-marketing safety reports and clinically approve all potential expedited reports prior to health authority submission
  • Responsible for identification, analysis, and reporting of possible adverse event trends and concerns regarding GBT products including identification and evaluation of safety signals
  • Provide input and reviews key regulatory or clinical documents (eg. protocol, Investigator Brochure, statistical analysis plans, clinical study report, DSUR, PADER, PBRER)
  • Lead multidisciplinary Pharmacovigilance Committee team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations to the global labeling team for safety issues, as appropriate; effectively communicate PV Committee outcomes to cross-functional senior leadership
  • Collaborate with Regulatory Affairs and other functional areas to design, implement, and oversee safety risk mitigation strategies (REMS, Risk Management Plan, Post-Approval Safety Surveillance) to ensure safe and appropriate use of GBT products in compliance with global regulatory requirements
  • Participate in multidisciplinary product labeling discussions for updates to the core data sheet and local product labels
  • Effectively lead Pharmacovigilance communications with senior management and governance committees, as applicable (eg. Senior Management Team, Product Development Team)
  • Participate in health authority interactions (both written and verbal) and inspections
  • Establish effective collaboration with medical leaders in Clinical Development and Medical Affairs and other GBT functional areas to align on harmonized approach in identifying, evaluating and communicating safety issues
  • Ensure compliance with global AE/SAE reporting requirements for all post-marketed products and products in development programs
  • Participate 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
  • Other duties, as assigned

  • MD (or equivalent) with 6+ years relevant pharmaceutical industry experience/expertise with 3+ years in Pharmacovigilance in a medical position. Post-marketing experience, a plus.
  • Experience in developing and implementing risk management strategies and plans
  • 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.