Director, Medical Safety Science (Risk Management)
Director, Medical Safety Science (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
[' Specific Responsibilities:
- 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
- Contribution to safety analyses in Regulatory submissions (e.g. Marketing Authorisation Application (MAAs), New Drug Application (NDAs))
- May participate in literature review process on an ad hoc basis
- 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
- Collaborates with partner companies on safety evaluation for co-licensed products
- Chairs cross functional safety committee meetings (internal or with partner companies); able to present complex information clearly
- Ensures timely review of protocols, informed consents and other study related documents for multiple products and therapeutic areas
- Participates on and may lead various cross-functional teams, involving interaction with Gilead staff within and external to GLPS, to convey and acquire drug safety information internally and externally
- Directs highly complex communications and ensures that all customers are fully informed and knowledgeable of project activities and their status
- May recruit, hire, and manage direct reports, with responsibility for employee performance evaluations
- Contributes to audits/inspections of systems and procedures to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to findings relevant to functional area
- Participates in both internal and external educational initiatives
- May participate in budget planning and management
Knowledge, Experience and Skills:
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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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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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