Temp Senior Safety Scientist

Responsibilities

• Responsible for safety oversight of clinical studies and the review and authoring of clinical trial protocols, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), and Development Safety Update Reports (DSURs).
• Additional safety-related activities include medical review of individual case safety reports (ICSRs), safety surveillance of assigned products, and active participation on cross-functional teams.
• Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety issues.
• Preparation and presentation of safety data summaries to internal and external stakeholders.
• Risk management activities, including medical review of ICSRs, routine review of safety data, and relevant scientific literature.
• Acquisition and contribution of knowledge related to drug class and/or competitor safety issues.
• Identification of potential clinical safety issues and recommendation of appropriate risk mitigation measures.
• Preparation and maintenance of relevant sections of: Clinical trial protocols, Investigator’s Brochures (including reference safety information), Informed Consent Forms (ICFs), DSURs, RMPs, CCDS, and labeling, as required.
• Safety review of clinical protocols, IBs, ICFs, and related documents to ensure alignment with safety strategy and risk communication plans.
• Accountability for safety components of: Clinical Study Reports (CSRs), Publications, Aggregate reports, and other regulatory documents.
• Conducting signal detection and evaluation activities for continuous benefit–risk assessment across the product lifecycle.
• Supporting implementation of signal evaluation decisions, including updates to core safety information and key safety documents.
• Contributing to regulatory filings (NDAs, BLAs) and responses to safety queries from regulatory agencies and third parties.
• Establishing and maintaining collaborative relationships with key stakeholders (study teams, CROs, investigators, study sites, vendors, and committees).
• Ensuring compliance with all governing laws, regulations, and standard operating procedures (SOPs).

Required Skills & Experience

• 3+ years of drug development experience in the pharmaceutical or related industry, including at least 1 year in drug safety.
• Proven ability to build and sustain strong partnerships with internal and external stakeholders.
• Broad understanding of safety science, pharmacovigilance (including GVP and GCP), clinical/patient risk management, and safety operations.
• Demonstrated ability to lead and influence in a fast-paced environment.
• Strong presentation skills and ability to summarize key considerations and decision points.
• Collaborative team mindset with a drive for innovation and continuous improvement.
• Strong attention to detail and ability to prioritize and work independently.
• Strong organizational skills and ability to interpret, discuss, and report trial-level data and identify trends.
• Excellent written and verbal communication skills.

Preferred Skills

• Independent leadership of drug safety activities for clinical programs, including signal evaluation and benefit–risk assessment.
• Experience authoring and reviewing key safety documents (e.g., DSURs, IB updates, protocol and CSR safety sections).
• Proven ability to represent safety on cross-functional teams.
• Demonstrated scientific judgment and ability to operate autonomously in a fast-paced environment.
• Exposure to global development programs and regulatory safety expectations.
• Experience improving pharmacovigilance processes or implementing new safety tools and technologies.
• Therapeutic area experience in oncology.