Senior Safety Scientist II

• The Senior Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities include:
• Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety signals.
• Prepare and present safety data summaries to internal and external stakeholders.
• Risk management activities include, but are not limited to medical review of ICSRs, routine review of safety data and pertinent scientific literature articles.
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
• Identify potential clinical safety issues and recommend appropriate risk mitigation measures.
• Involvement in preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.
• Accountable for the safety components of study reports (i.e., CSRs), publications, aggregate reports, and other regulatory documents.
• Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.
• Contributes to input related to regulatory filings, New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
• Establish and maintain collaborative working relationships with all key stakeholders (study team members, CROs, investigators, study sites, vendors, committees, etc.).
• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.
• Independently represents Safety Science at cross-functional team meetings.
• Contributes to the development of SOPs and Safety Science processes.
• A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).
• 5 or more years of drug development experience in the pharmaceutical or related industry with at least 3 years in drug safety.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
• Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management and safety operations.
• Demonstrated ability to lead and influence, with and without authority, in a fast-paced environment.
• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Detail-oriented with ability prioritize tasks and function independently as appropriate.
• Strong organizational skills and an ability to interpret, discuss, and report trial level data effectively and identify trends.
• Excellent written and verbal communication skills.

None flagged.