Safety Scientist Contract Consultant
700 Saginaw Drive Redwood City, CA 94063 US
Job Description
Safety Scientist Contract ConsultantÂ
The Opportunity:
The Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the portfolio, which includes early and late phase development activities. The individual will be responsible for supporting clinical studies, review of clinical trial protocols, supporting updates to IBs, ICFs, and authoring of DSURs. Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.
The Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities include:
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Proactive medical safety surveillance of ongoing clinical trials for identification of safety
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Conduct ongoing safety data reviews; prepare and present summaries to internal stakeholders.
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Medical review of individual case safety reports, routine review of safety data and pertinent scientific literature articles.
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Identify potential clinical safety issues for ongoing clinical trials based on emerging safety data.
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May perform safety reviews of relevant sections of clinical trial protocols, Investigator’s Brochures (including reference safety information), clinical study reports, informed consent forms, DSURs, and other study related documents, as required.
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Supports authoring or otherwise contributes to the preparation of aggregate safety reports and risk management plans (RMPs).
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Conducts signal detection and evaluation activities for assigned products in collaboration with senior Safety Science team member(s) as part of the continuous benefit-risk evaluation throughout the product lifecycle.
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Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, study sites, CROs).
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Consistently comply with all governing laws, regulations, standard operating procedures (SOPs) and other guidelines.
Required Skills, Experience and Education:
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A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).
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2 or more years of drug development experience in the pharmaceutical or related industry.
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Detail-oriented with ability prioritize tasks and function independently as appropriate.
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Strong learning orientation, curiosity, and commitment to science and patients.
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Excellent written and verbal communication skills.
Preferred Skills:
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Understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management?.
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Exposure to Safety Operations and experience with individual case review.
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Knowledge and/or experience with clinical trial management and data review.
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