Product Safety Scientist - Remote Position

Location
South San Francisco, CA
Posted
Jul 21, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

PRODUCT SAFETY SCIENTIST – (REMOTE POSITION)

Position Summary:

Global Blood Therapeutics is seeking a leader to carry out safety risk management functions for GBT investigational and marketed products.  The Product Safety Scientist will support members of GBT Pharmacovigilance Product Safety Teams, including the Product Safety Officer and Product Medical Safety Scientist in carrying out critical pharmacovigilance activities such as signal detection/management, risk management activities, and overall benefit-risk management of assigned products. The Product Safety Scientist will report to the Senior Director of Pharmacovigilance & Risk Management Business, Strategy and Compliance.

Essential Duties and Responsibilities:

  • Work with the Product Safety Officer or Product Safety Medical Scientist in carrying out key signal detection activities including completing the signal detection strategy form, review of routine signal detection outputs such as clinical trial (SAES) and post marketing monthly line listings, monthly literature reviews in order to evaluate and detect new safety signals
  • Under the direction of the Product Safety Officer draft safety assessment reports and contribute to the drafting, review, and completion of aggregate reports such as PADERs, DSURS, PBRERS
  • Work with the Product Safety Officer or Product Safety Medical Scientist in drafting key safety sections of the clinical trials related safety documents such as the Risks and Discomfort Section of the Informed Consent Form, Investigator Brochure, clinical safety reports, statistical analysis plans, safety data collection forms, or safety sections of key documents for regulatory filings such as the Summary of Clinical Safety and Clinical Overview.
  • Assist the Product Safety Officer in creating/revising Risk Management Plans for GBT products, as well as local risk management plans, and assess the effectiveness of approved risk minimization activities.
  • Work the Product Safety Officer and EU QPPV in assessing Post Marketing Authorization Safety Studies,
  • Work with the Product Safety Officer on creating presentations that summarize the Product Safety Team's recommendation on safety issues to be presented at the Cross-Functional Safety Team (CFST) and Drug Executive Safety Team (DESC) (cross functional decision-making bodies).
  • Support the Product Safety Officer in providing safety oversight for on going clinical trials including reviewing data from clinical trials and study related document.
  • Work with GBT Pharmacovigilance senior leadership team to ensure inspection readiness and support internal audits to ensure quality and compliance throughout the PV organization.
  • Work with the Product Safety Officer to respond to regulatory enquiries.

Qualifications:

  • Doctorate degree and 2+ years of pharmacovigilance experience or BS / MS degree and 6+ years of pharmacovigilance experience.
  • Strong written and verbal communication skills
  • Strong knowledge of global regulatory adverse event reporting requirements and pharmacovigilance guidance and practices including signal detection and evaluation, periodic report planning and production, risk management.
  • Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
  • Team player with strong interpersonal skills and the ability to function in a multi-disciplinary environment.
  • Self-motivated, able to prioritize and plan effectively.
  • Detail-oriented with good organizational and time management skills

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.