Senior Safety Scientist I

The Senior Safety Scientist I within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities. The individual will be responsible for safety oversight of clinical studies, review and authoring of clinical trial protocols, IBs, ICFs, and 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 Senior Safety Scientist I 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.

• Perform safety review of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.

• Accountable for the safety components of study reports (i.e., CSRs), publications, aggregate reports, and other regulatory documents.

• Conducts signal detection and evaluation activities for assigned products for the continuous benefit-risk evaluation throughout the product lifecycle and contributes/leads preparation for escalation to safety governance committees.

• 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.