Safety Scientist

Responsibilities

• Proactive medical safety surveillance of ongoing clinical trials for identification of safety
• Conduct ongoing safety data reviews; prepare and present summaries to internal stakeholders
• Medical review of individual case safety reports and medical review of ICSRs, routine review of safety data and pertinent scientific literature articles
• Identify potential clinical safety issues for ongoing clinical trials based on emerging safety data
• 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
• Supports authoring or otherwise contributes to the preparation of aggregate safety reports and risk management plans (RMPs)
• 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
• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, study sites, CROs)
• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines

Qualifications

• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications)
• 1 or more years of drug development experience in the pharmaceutical or related industry
• Understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management and/or safety operations
• Demonstrated ability to lead and influence in a fast-paced environment
• Strong organizational and presentation skills, effective at summarizing and presenting the key considerations and decision points
• Strong learning orientation, curiosity, and commitment to science and patients
• Excellent written and verbal communication skills

Benefits

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $120,000 - $150,000 USD.