Drug Safety Manager

Senior Drug Safety Case Manager The Senior Drug Safety Case Manager supports both clinical trial and post-marketing pharmacovigilance activities within a growing pharmaceutical organization. This role provides immediate coverage for a team member on leave while helping manage increasing post-marketing case volumes following a first commercial product launch. The position is highly hands-on, with broad responsibility across case processing, quality control, vendor oversight, regulatory submissions, reconciliation, and operational backup coverage in a lean, flexible team environment. Responsibilities Perform quality control of clinical trial safety cases processed internally to ensure accuracy, completeness, and compliance with regulatory requirements. Support hands-on clinical trial case processing, including case data entry and end-to-end case management, as business needs require. Review and perform QC on post-marketing safety cases processed by external vendors to verify data integrity and adherence to procedures. Write and review clear, medically relevant case narratives that accurately reflect clinical information and safety assessments. Draft and review appropriate company comments for individual cases to support consistent regulatory communications. Assess case reportability, expectedness, seriousness, and submission requirements in accordance with applicable regulations and guidelines. Review medical coding and identify errors or inconsistencies in coding and case-processing activities. Use safety labeling documents and product information to support case assessment and determine expectedness and reportability. Review vendor-generated triage notifications and quickly identify errors or issues affecting regulatory case submissions and cross-reporting requirements. Conduct SAE reconciliation across clinical studies or provide backup support for reconciliation activities to ensure alignment between safety and clinical databases. Support post-marketing vendor reconciliation activities to confirm that all relevant safety data are captured and processed correctly. Provide submission compliance oversight as needed, ensuring cases are submitted accurately and within required timelines. Support product quality complaint reconciliation when applicable, coordinating with relevant teams to align safety and quality data. Queue internally processed clinical trial cases for appropriate review and submission pathways. Serve as backup coverage for clinical study leads and post-marketing team members to maintain continuity of safety operations. Shift efficiently between clinical trial and post-marketing workloads based on case volume, priorities, and team availability. Support general pharmacovigilance operational activities, including mailbox monitoring and other routine safety operations tasks when needed. Collaborate closely with internal safety operations, safety science, European pharmacovigilance, clinical study teams, post-marketing teams, and outsourced vendor partners. Adapt to changing vendors, processes, territories, and operating procedures as the organization expands its commercial footprint and product portfolio. Essential Skills Senior-level experience in pharmacovigilance or drug safety operations, with a strong focus on case processing and safety operations. Extensive hands-on case-processing experience in both clinical trial and post-marketing environments. Demonstrated experience performing individual case quality control for clinical and post-marketing safety reports. Proven ability to write and review high-quality, medically sound safety narratives and company comments. Strong understanding of regulatory reporting requirements, case reportability criteria, and submission timelines across different regions. Experience conducting SAE reconciliation across clinical studies to ensure data consistency between clinical and safety systems. Experience reviewing medical coding and identifying issues related to coding terminology and case-processing accuracy. Ability to use safety labeling documents and product information to support case assessment, expectedness evaluation, and reportability decisions. Experience reviewing vendor-processed cases and triage notifications, with the ability to identify errors and gaps in case handling. End-to-end understanding of case processing workflows across both clinical trial and post-marketing pharmacovigilance settings. Solid grasp of regulatory submission timelines, cross-reporting requirements, and compliance expectations in drug safety. Argus Safety experience strongly preferred, including use of Argus as the primary safety database. Ability and willingness to perform hands-on operational work, such as data entry, QC, and reconciliation, regardless of seniority. Ability to work effectively in a fast-paced, lean, and rapidly changing organization with evolving products, vendors, and territories. Flexible, collaborative working style with a willingness to wear multiple hats and support a wide range of safety operations tasks. Ability to quickly learn new studies, products, vendors, processes, and geographic reporting requirements. Additional Skills & Qualifications Experience in both clinical trial and post-marketing pharmacovigilance operations, including case processing, QC, and vendor oversight. Background in a pharmaceutical or biotechnology environment transitioning from development stage to commercial stage. Experience supporting US and European commercial safety activities, including interaction with QPPV and European pharmacovigilance functions. Comfort working within a lean team structure where Senior staff remain hands-on and collaborative. Ability to manage broad responsibilities across submissions, reconciliation, mailbox monitoring, and operational backup coverage. Strong interpersonal and communication skills to collaborate effectively with cross-functional internal teams and external vendors. Adaptability to changing vendors, territories, operating procedures, and commercial expansion. Interest in potential long-term engagement, with opportunities for contract extension or future conversion based on performance and business needs. Work Environment This role operates within a fast-paced pharmaceutical or biotechnology environment that is transitioning from development to commercial stage. The Drug Safety Operations team is lean and utilizes both in-house and outsourced case-processing models, offering exposure to a wide range of safety activities. You collaborate closely with Safety Science, European pharmacovigilance (including QPPV functions), clinical study teams, post-marketing teams, and external vendor partners. Argus is the primary safety database used for case management and regulatory reporting. The position follows a hybrid workplace model, with remote flexibility available for the immediate contract need, and emphasizes a collaborative culture where Senior team members remain hands-on and accessible. Job Type & Location This is a Contract position based out of South San Francisco, CA. Pay and Benefits The pay range for this position is $75.00 - $95.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in South San Francisco, CA. Application Deadline This position is anticipated to close on Jul 25, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. 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