Pv Operations Medical
2 weeks ago
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
**Job Description**:
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- Performs quality control (QC) of adverse event reports from a medical review perspective- Participates in both internal and external educational initiatives- Initiate, lead, or contributes to a functional or cross-functional project- Participates in process improvement initiatives by identifying areas for improvement and presents solutions- May serve on higher level intradepartmental and interdepartmental cross-functional projects- May lead or contribute to develop and maintain procedural document and provide training- Supports internal and external audit and inspection- Establishes recognition as an expert on medical safety assessment of individual cases- Provides support to Coding Strategy group on an ad hoc basis- Provides medical consultation and training to PS Operations group including Literature Management and Autolabeling Management on an ad hoc basis
Essential Duties and Job Functions- Provides mentorship and trains junior staff, new hires, and contractors to independently review adverse event reports for investigational and marketed products- Makes contributions to process improvement within PS, particularly with adverse event processing and operational aspects of medical review- May recruit, hire, mentor, and manage direct reports, with responsibility for team members’ performance evaluations- Provides training and oversight to CRO
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- Experience in medical review or an applicable role in the pharmaceutical industry with a general understanding of relevant regulatory requirements or an exceptional track record of excellence in clinical practice- Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications- Proven ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously- Demonstrates independence in effectively managing teams- Demonstrates strong leadership skills with a sphere of influence externally and within PS- 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:
Please log onto your
Internal Career Site
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