Risk Management Senior Director, Medical Safety Sciences

Location: Foster City, California US

Notice

This position is no longer open.

Job Number: 1733

External Description: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
Performs and/or oversees risk management (RM) activities for multiple products or a complex product, provides strategic input and/or management oversight, and leads complex projects or analyses.

Job Responsibilities:

Work is performed with minimal supervision following Gilead procedures:
▪ Authors and/or oversees the authoring of aggregate pharmacovigilance (PV) reports and risk management plans (RMPs)
▪ Supervision/oversight of QC/QC metrics generation
▪ Conducts and/or oversees signal detection and evaluation activities in collaboration with Medical Safety Science Medical Evaluation (MSS-ME) team as part of the continuous risk/benefit evaluation throughout the lifecycle of developmental and marketed products
▪ Chairs cross functional safety committee meetings
▪ Oversees and contributes to activities related to regulatory filings (e.g., MAAs, NDAs) from a RM perspective, and responses to safety queries from third parties, such as regulatory agencies
▪ Participates on and may lead complex projects, involving interaction with Gilead staff within and external to PVE
▪ Leads complex route-cause analyses and identifies solutions with consideration of the impact on processes within and external to PVE
▪ Manages highly complex communications and ensures that all customers are fully informed of project activities.
▪ Represents MSS functional area at PV audits and inspections
▪ Mentors less experienced colleagues to gain necessary RM knowledge and skills
▪ May recruit, hire, and manage direct reports, with responsibility for employee performance evaluations

Knowledge & Skills:

▪ Expert knowledge and understanding of good pharmacovigilance practices and worldwide PV regulations and their application to RM activities, including on aggregate PV reports, RMPs, signal detection, clinical trials, and clinical development
▪ Excellent scientific/clinical and analytical knowledge base with ability to assess data and understand the safety/medical implications
▪ In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies
▪ Good knowledge of statistical methods used in PV


For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Number: R0013975

Community / Marketing Title: Risk Management Senior Director, Medical Safety Sciences

Location_formattedLocationLong: Foster City, California US

 

CONNECT WITH US