Director, Pharmacovigilance Safety Surveillance

We are seeking a highly skilled and experienced Director of Safety Surveillance to lead and oversee the safety surveillance activities. The Director will be pivotal in ensuring timely review, identification, evaluation and communication of safety signals for our innovative immunological therapies. This role involves managing a cross-functional team, developing and implementing safety surveillance strategies, and ensuring compliance with global regulatory requirements. The Director will work closely with Clinical Development, Regulatory Affairs and Biometrics teams to monitor, analyze, and report aggregate safety data, to support clinical and regulatory activities throughout the product lifecycle.

Key Responsibilities

• Lead and mentor a team of safety surveillance professionals to effectively monitor product safety profiles and risk management strategies.
• Develop and implement safety surveillance strategies across all phases of clinical development and post-marketing, as applicable.
• Provide guidance and actively participate in safety risk assessment, signal detection, benefit-risk evaluation, and pharmacovigilance activities for early to late-stage drug development.
• Lead preparation and submission of safety-related regulatory documents, including DSUR, PBRER and risk management plans (RMPs), and other documents to support regulatory filing activities.
• Lead ad hoc safety analysis activities and the preparation of safety response to safety inquiries from regulatory authorities.
• Conduct safety signal detection and risk management assessments, ensuring timely and accurate communication of safety findings.
• Lead the regular safety review meetings and contribute to discussions on safety data interpretation, safety signal assessment and risk mitigation strategies.
• Develop global literature search strategies, manage literature surveillance activities.
• Work closely with clinical, regulatory, and medical affairs teams to integrate safety surveillance information into clinical development strategies.
• Ensure compliance with applicable global regulatory requirements (FDA, EMA, ICH, etc.) and pharmacovigilance guidelines.
• Communicate risk findings to internal stakeholders, regulatory authorities, and external partners as necessary, maintaining transparency and compliance.
• Drive continuous improvement of safety surveillance processes and implement best practices.

Qualifications

• Advanced degree in Life Sciences (PhD, MD, PharmD, or equivalent) is required, degree in immunology or neurology is preferred.
• Minimum of 8-10 years of experience in safety surveillance in the biotech or pharmaceutical industry, with at least 3 years in a leadership role.

Skills & Competencies

• Extensive knowledge of pharmacovigilance regulations and guidelines, e.g. FDA, EMA, ICH, and other global regulations and guidelines.
• Strong leadership, strategic thinking, and decision-making skills.
• Expertise in adverse event reporting, risk management, and safety data analysis.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
• Excellent communication and interpersonal skills with the ability to influence and build relationships across departments.
• Proficiency with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault).
• Experienced in safety data analysis, including analyzing trends and patterns in large datasets.

Desired Attributes

• Strong problem-solving and critical-thinking skills.
• Collaborative mindset with a focus on patient safety and regulatory compliance.
• Ability to work independently while leading a team and collaborating across departments.
• Passion for advancing biotechnological innovations to improve patient outcomes.

The salary range for this position is $260,000 USD to $280,000 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.

*Lab personnel are generally onsite 4-5 days/week.