Associate Director, Pharmacovigilance & Epi RM
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 ResponsibilitiesSignal 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. Periodic Safety Update Reports (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's 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 with minimal supervision
Essential Duties and Job Functions
Offers significant contributions to safety committee meeting discussions (internal or with partner companies)
Responsible for presenting results and findings and discussing processes in formal settings with consideration of the impact on processes within and external to GLPS
Participates on and may lead various cross-functional teams involving interaction with Gilead staff within and external to GLPS
Leads multiple projects simultaneously with minimal supervision
Leads the analysis and resolution of complex problems collaboratively with cross-functional staff
May write drug safety SOPs and contribute to drug safety audits or inspections
May manage direct reports with responsibility for employee performance evaluations
Evaluates performance and task management of junior employees
Acts as a mentor to junior employees
Work is performed under minimal supervision following established procedures
Establishes recognition within GLPS as an expert in pharmacovigilance
Anticipates complex problems which may arise and resolves them in a collaborative manner
Demonstrates independent thought and initiative in the preparation and completion of projects
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
Significant experience in drug safety is preferred
Excellent knowledge of pharmacovigilance regulations, aggregate safety reports, risk management plans, signal detection, clinical trials and clinical development
Demonstrates proficiency in verbal and written communication, including Microsoft Office, Excel, Word, and PowerPoint
Demonstrates excellent attention to detail, project management skills, teamwork and initiative; maintains meticulous attention to project deadlines
Demonstrates ability to influence others at the same or more junior levels within the organization
Demonstrates excellent interpersonal and communications skills and ensures that all customers are fully informed and knowledgeable of project activities and their status
Demonstrates ability to assess complex data sets and understand the safety/medical implications
Demonstrates understanding of observational studies used in pharmacoepidemiology
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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