Product Safety Officer (Senior Medical Director), Pharmacovigilance & Risk Management

Location
San Francisco, CA, United States
Posted
Jul 20, 2021
Ref
1124
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
PRODUCT SAFETY OFFICER (SENIOR MEDICAL DIRECTOR),

PHARMACOVIGILANCE & RISK MANAGEMENT

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 assessments of safety data outputs to characterize the emerging and known safety profiles for all GBT products. The Product Safety Officer (PSO) will ensure successful implementation, execution, and maintenance of safety-related strategies, processes and systems that adhere to global pharmacovigilance standards, and ensure compliance with applicable local laws and regulations. The PSO will support the Pharmacovigilance leadership team in building a world class pharmacovigilance department that is part of an organization whose mission is to improve the care of people living with sickle cell disease

The PSO will report directly to the Vice President of Pharmacovigilance & Risk Management.

Essential Duties and Responsibilities:

  • As the PSO , establish the signal detection strategy for assigned products, oversee the implementation of the signal detection strategy including signal detection, signal analysis, signal validation, signal prioritization, signal assessment, and , and providing recommendations on appropriate safety actions including updating of core reference safety documents (e.g. core data sheet, local labels, risk management plan)
  • Responsible for leading the Safety Analysis Team (SAT) and co-chair the Cross-Function Safety Team, and a core member of the Clinical Study Team
  • Providing safety input to other cross-functional teams such as the labelling group, study execution teams, or the Product Development Team
  • Create and maintain the core safety sections of reference safety documents including the IB, ICF, CDS and local labels
  • Create and maintain the core risk management plan as well as any required local risk management plans and communicate the overall Benefit-Risk profile of assigned product (s)
  • Prepare and provide oversight for the development of aggregate reports such as the DSUR, FDA PADERs, EU PBRER, and other required aggregate reports
  • Prepare/review and provide input for relevant safety sections of regulatory documents such as statistical analysis plans, clinical study reports, protocols, INDs, NDAs, sNDAs, EU MAA and other regulatory filings
  • Prepare high quality safety presentations or the senior safety governance committee for their review and endorsement
  • Assist the VP of Pharmacovigilance & Risk Management in ensuring the department is inspection ready
  • When required, provide input to the Medical Safety Reviewer regarding, causality, seriousness, expectedness, and developing follow-up queries to complete the case management process for Individual Case Safety Reports (ICSRs)
  • Provide medical opinions regarding potential product quality issues
  • Provide input to assessment of non-clinical findings and medical impact to patients
  • Collaborate with Regulatory Affairs and other functional areas to design, implement, and oversee safety risk mitigation strategies (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. Clinical Safety Team, Study Execution Team)
  • Participate in health authority interactions (both written and verbal) and inspections
  • Establish effective collaboration with medical leaders in Clinical Development, Medical Affairs, and other GBT functional areas to align on a harmonized approach in identifying, evaluating and communicating safety issues
  • 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
  • Domestic and international travel up to 20%


Qualifications:

  • MD (or equivalent) from an accredited medical school with 7+ years relevant pharmaceutical industry experience/expertise with 3+ years in Pharmacovigilance in a medical position. Post-marketing experience, a plus
  • 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
  • Excellent written and verbal skills
  • 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 in a matrix environment
  • 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.