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 a Medical Safety Science Medical Evaluation (MSS-ME) team member
- Authorship of Company Core Data Sheet (CCDS) sections and associated supporting documentation
- Authorship of aggregate safety reports (e.g. PSURs)
- Authorship of risk management plans
- Authorship of responses to regulatory agency safety enquiries
- Contributes to safety analyses in Regulatory submissions (e.g., Marketing Authorization Application (MAAs), New Drug Application (NDAs))
- Reviews global literature for identification of potential safety concerns
- Performs safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies
- Reviews standard reference documents in collaboration with a MSS-ME team member
Essential Duties and Job Functions
- Works and leads projects with minimal supervision following established procedures
- Demonstrates ability to present results and findings and discuss processes in formal settings with consideration of the impact on processes within and external to GLPS
- Demonstrates ability to analyze and resolve complex problems collaboratively with cross-functional staff
- Recognized within the job family as a technical expert
- Independently searches drug safety and literature databases for relevant information
- Collaborates with partner companies on safety evaluation for co-licensed products with some supervision as needed
- Makes good contributions to safety committee meeting discussions (internal or with partner companies)
- Participates on and may lead various cross-functional teams involving interaction with Gilead staff within and external to GLPS
- Maintains a successful track record of developing contacts within GLPS and across the company and using those contacts to manage projects more effectively
- Demonstrates the ability to work effectively with MSS-ME, other members of GLPS, and colleagues external to GLPS
- May participate in drug safety audits or inspections
Knowledge, Experience and Skills
- Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g. biology, chemistry, or neuroscience) with demonstrated experience with the responsibilities, deliverables, and skills required for this level
- Moderate level (4+ years) of experience in drug safety is preferred
- Demonstrates proficiency in verbal and written communication, including Microsoft Excel, Office, Word, and PowerPoint
- Demonstrates good project management skills, excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
- Demonstrates ability to assess complex data sets and understand the safety/medical implications
- Communicates effectively to ensure relevant parties are fully informed and knowledgeable of project activities and their status
- Possesses good knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development
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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 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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