Senior Manager, Risk Management (RM), GLPS-MSS

Foster City
See job description.
September 14 2021
Position Type
Full Time
Organization Type
Job Type

Senior Manager, Risk Management (RM), GLPS-MSS
United Kingdom - Cambridge

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
  • Contributes to safety analyses in Regulatory submissions (e.g., Marketing Authorisation 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
  • May manage direct reports with responsibility for employee performance evaluations
  • May act as a mentor to junior employees

    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 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

    Equal Employment Opportunity (EEO)
    It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

    For Current Gilead Employees and Contractors:

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