Ireland - Dublin
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 Reviews adverse reports received for marketed and investigational products, adhering to standard operating procedures for medical assessment of individual case safety reports providing safety assessment and pharmacovigilance comment
Collaborates with Medical Safety Science - Risk Management (RM) in the identification and assessment of safety signals and trends; presentation of medical safety review to product safety committees and senior management, and supports management of any potential safety issues; provides medical review of aggregate reports such as periodic safety update report (PSURs) and other periodic safety reports
Contributes to preparation and review of safety documents in response to regulatory inquiries
Participates in audits, data analysis, and other ad hoc activities
Participates in both internal and external educational initiatives
Contributes to, and may manage, a critical component of a functional or cross-functional project
May lead and initiate functional area projects
Participates in process improvement initiatives by identifying areas for improvement and presents solutions
May serve as medical monitor for post-authorization safety studies
May serve on higher level intradepartmental and interdepartmental cross-functional projects and /or clinical sub-teams when appropriate
Participates in standard operating procedure (SOP) updates, audits, data analysis, and other ad hoc activities
Establishes recognition as an expert on medical safety assessment of individual cases
Essential Duties and Job Functions
Provides medical safety review and/or sign off for wide variety of safety documents, both within GLPS and cross functionally, including clinical study protocols, investigator brochures (IB), clinical study reports (CSRs), reference safety information (RSI), regulatory documents, and other documents for investigational and marketed products
Performs continuous risk/benefit evaluation throughout the lifecycle of various assigned innovative products
Knowledge, Experience and Skills
Requires an MD/DO degree or equivalent
Requires completion of an accredited medical or surgical residency program. Board certification is preferred
Should have either (1) minimum of 2 years experience in a pharmacovigilance or applicable role in the pharmaceutical industry with a general understanding of relevant regulatory requirements OR (2) an exceptional track record of excellence in an area including clinical research, health administration, health policy, epidemiology, or academic or subspecialty medicine
Demonstrates deep understanding of pharmacovigilance practices including MedDRA coding and worldwide safety regulations and guidelines
Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
Acknowledged by cross-functional teams as internal safety and pharmacovigilance product-specific expert
Proven ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously
Shows confidence and expertise in handling complex clinical and post - marketing medical safety cases, and providing medical input in risk management activities
Demonstrates confidence in the presentation of safety reviews to safety committees and senior management
Demonstrates the ability to handle increasing and/or changing responsibilities (e.g. team growth, integration efforts across other departments or the organization)
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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