Job Description

Job Title: Senior Safety Scientist / Safety Science Lead

Location: Sacramento, CA (On Site)

Job Type: W2 Contract

Department: Pharmacovigilance / Drug Safety

Job Description:

We are seeking a highly experienced and driven Senior Safety Scientist to lead and execute the comprehensive safety evaluation strategy for investigational and marketed products. The successful candidate will be responsible for driving safety signal identification and evaluation, supporting clinical trial safety oversight, and contributing to global regulatory safety reporting and risk management activities across all phases of clinical development.

Key Responsibilities:

Safety Signal Management and Evaluation

• Lead the identification, analysis, and evaluation of safety signals using both individual and aggregate safety data.
• Define and implement data acquisition strategies, methodologies, and analytical approaches for signal detection and safety evaluations.
• Author and present safety assessments, including risk evaluation and recommendations for further action, at safety governance bodies (e.g., Safety Management Team [SMT], Company Safety Committee [CSC]).
• Initiate and lead proposals for SMT discussions and ensure alignment with cross-functional teams.
• Develop and maintain signal assessment documentation in accordance with client signal management frameworks and internal safety governance procedures.
• Communicate safety-related findings and insights to internal stakeholders, core teams, and business partners in a timely and efficient manner.

Clinical Trial Support

• Serve as the safety lead for assigned clinical trials (Phase 1–3), overseeing patient safety monitoring and aggregate data review.
• Lead the review and contribute to the development of key clinical trial documents, including Protocols, Investigator Brochures (IBs), Informed Consent Forms (ICFs), Safety Analysis Plans (SAPs), and Clinical Study Reports (CSRs), including China-specific regulatory summaries.
• Participate in the design and review of Medical Monitoring Plans and provide expert responses to ad-hoc safety queries from ethics committees and cross-functional teams.
• Contribute to the development and review of Safety Management Plans and provide input for Safety Monitoring Committees (SMC), Data Monitoring Committees (DMC), and Data and Safety Monitoring Boards (DSMB).

Regulatory Safety Reporting and Risk Management

• Lead the authoring of safety sections for global regulatory documents including DSURs, PSURs, PADER/PAERs, PBRERs, and Risk Management Plans (RMPs).
• Coordinate and lead strategy development for addressing regulatory safety inquiries from global health authorities and institutional review boards/ethics committees (IRBs/ECs).
• Collaborate with the Safety Science team and other cross-functional partners to develop and review safety communication documents (e.g., DHCP/DHPC letters, Dear Investigator Letters, labeling documents).

Qualifications:

• Education: PharmD, NP, RN, or PhD in a medical or biological science discipline.
• Experience: Minimum 8 years of relevant experience as a Safety Scientist or Pharmacovigilance professional in the pharmaceutical or biotechnology industry.
• Strong knowledge and hands-on experience with safety data analysis, signal detection, aggregate safety review, and risk management across clinical trial phases.
• Proficiency in developing and reviewing clinical and regulatory documents related to patient safety and pharmacovigilance.
• In-depth understanding of global regulatory safety reporting requirements and pharmacovigilance best practices.
• Demonstrated experience working in cross-functional, matrixed teams in a global environment.

Preferred Skills:

• Expertise in signal detection and evaluation methodologies.
• Experience supporting SMCs/DMCs/DSMBs.
• Strong communication skills with the ability to interpret and convey complex safety data to scientific and non-scientific audiences.
• Proficiency with safety databases and analytical tools is a plus.

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