Safety Surveillance Scientist

Job Details

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

We are seeking a highly skilled Pharmacovigilance (PV) Scientist with expertise in autoimmune disorders to join our team. This role is pivotal in ensuring timely review, identification and communication of safety signals for our innovative immunological therapies. The successful candidate will be responsible for aggregate review, evaluation, and analysis of safety information from ongoing clinical studies, supporting clinical and regulatory activities.

Key Responsibilities

• Continuously review and analyze safety data from ongoing clinical studies to monitor and identify any emerging safety signals or trends.
• Perform detailed and aggregate analysis of safety data to detect trends, potential risks, and emerging safety issues associated with the investigational products.
• Conduct signal detection activities to identify, and characterize potential safety signals from clinical trials and various safety data sources.
• Prepare and submit detailed signal detection reports to regulatory agencies, ensuring compliance with regulatory requirements and guidelines.
• Support safety responses to address any regulatory queries or concerns related to safety signals or aggregate safety reports
• Perform literature surveillance activities, develop and maintain search strategies to ensure comprehensive safety evaluations and identify any new or unexpected safety issues from published medical literature
• Support the development of aggregate safety reports, including development safety update reports (DSUR) and other expedited safety reports
• Monitor and track all safety action items from safety oversight committees to ensure timely implementation of any risk mitigation strategy
• Lead the regular safety review meetings and contribute to discussions on safety data interpretation, safety signal assessment and risk mitigation strategies.

Qualifications

• Education: Pharm.D., Master, or Ph.D. in immunology, or a related field.
• Experience: Minimum of 3-5 years of relevant experience in safety surveillance within the biopharma industry.
• Technical Skills: Proficiency with MedDRA, Argus, and Veeva Vault and experience in safety signal detection and risk management.
• Experience in safety data analysis, including analyzing trends and patterns in large datasets.
• Regulatory Knowledge: Solid understanding of FDA, ICH, EMA, and other global pharmacovigilance regulations and safety reporting requirements.
• Soft Skills: Strong analytical and problem-solving abilities, meticulous attention to detail, and excellent communication skills.
• Certifications: Certification in pharmacovigilance or related fields is advantageous.

Preferred Qualifications

• Experience managing safety for biologics or advanced therapeutic products.
• Familiarity with immunology-specific safety profiles and adverse event management.
• Prior experience in clinical research or drug development settings.

The salary range for this position is $150,000 USD to $170,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. At this time we are not considering remote applicants.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.

Other benefits include:

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient's lives-- and we aspire to elevate, challenge and nurture one another along the way.