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

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

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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:
Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Cambridge/Senior-Manager--Risk-Management--RM---GLPS-MSS_R0022192-1





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