Senior Manager, Risk Management
Senior Manager, Risk Management
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
- Signal detection and authorship of signal work-up documents in collaboration with the Safety Physician
- Preparation of sections and associated supporting documentation for Development Core Safety Information (DCSI) and Company Core Data Sheet (CCDS)
- Preparation of aggregate safety reports such as Development Safety Update Report (DSUR) and Periodic Benefit-Risk Evaluation Report (PBRE)/Periodic Safety Update Report (PSUR)
- Preparation of risk management plan (RMP)
- Preparation of responses to safety enquiries from the Regulatory Agency
- Contribution to safety analyses in regulatory submissions such as Marketing Authorization Application (MAA) and New Drug Application (NDA)
- Review of global literature for identification of potential safety concerns
- Review of safety related sections of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies
- Review of standard reference documents
Essential Duties and Job Functions:
- Works and leads assigned projects with minimal supervision following established procedures
- Demonstrates the ability to work effectively with the safety physician and other team members
- Demonstrates ability to present results and findings and discuss processes in cross-functional meetings
- Demonstrates ability to analyze and resolve complex problems and understand the safety and medical implications
- Communicates effectively and collaborate closely with cross-functional team members
- Familiar with searching drug safety and literature databases for relevant information
- May act as a mentor to employees with less experience
Knowledge, Experience and Skills:
- Requires a degree (e.g., BS, BA, MSc or PhD) in bioscience or professional qualification in a health science field (e.g., Nursing or Pharmacy)
- Moderate experience in drug safety and risk management is preferred
- Possesses good knowledge of pharmacovigilance and safety regulations
- Demonstrates proficiency in verbal and written communication, including Microsoft Excel, Office, Word, and PowerPoint
- Demonstrates excellent attention to detail and good project management skills
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 email@example.com opens new window" target="_blank" href="https://apptrkr.com/get_redirect.php?id=2499274&targetURL=mailto:firstname.lastname@example.org">email@example.com for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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:
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