Job Description

Job Title:Associate Medical Director, Safety Science

Department:Patient Safety

Reports to:Applicable Safety Science Manager/Leader

Location:United States (San Rafael, CA); Open to hybrid

ROLE SUMMARY

The Associate Medical Director of Safety Science provides medical expertise to support safety surveillance activities for assigned products. You will contribute to pharmacovigilance (PV) operations, perform medical safety assessments, assist with regulatory activities, and support the implementation of safety monitoring practices. This role offers the opportunity to develop clinical and regulatory expertise while ensuring patient safety and supporting product development goals.

KEY RESPONSIBILITIES

Medical Safety Support

• Support safety physician activities for assigned products under medical director guidance
• Assist with safety signal detection and evaluation processes
• Review individual case safety reports (ICSRs) and contribute to medical assessments
• Support medical interpretation of safety data and causality evaluation activities
• Attend safety review meetings and contribute to cross-functional safety discussions

Safety Operations

• Assist in the execution of pharmacovigilance activities for assigned products
• Support risk management plan implementation and monitoring activities
• Contribute to benefit-risk evaluation processes under supervision
• Collaborate with clinical teams on safety-related activities
• Assist in preparing safety content for regulatory documents

Regulatory Activities

• Assist in the execution of pharmacovigilance activities for assigned products
• Support risk management plan implementation and monitoring activities
• Contribute to benefit-risk evaluation processes under supervision
• Collaborate with clinical teams on safety-related activities
• Assist in preparing safety content for regulatory documents

Professional Development and Collaboration

• Work closely with senior PV staff to develop medical safety expertise
• Support training and guidance of PV scientists and support staff
• Contribute to standard operating procedure reviews and updates
• Participate in departmental improvement initiatives
• Collaborate with affiliate teams on safety-related projects

Scientific Learning and Growth

• Stay informed about current safety methodologies and regulatory updates
• Attend scientific conferences and training programs to build expertise
• Support preparation of safety-related publications and presentations
• Assist with post-market safety study activities
• Learn and apply emerging safety assessment techniques

QUALIFICATIONS

Education and Experience

• You hold an MD or equivalent medical qualification (active license to practice preferable but not required)
• You bring 2-5 years of pharmaceutical industry PV experience or relevant clinical experience
• You have basic understanding of regulatory processes

Technical Knowledge

• Good understanding of global PV regulations and guidelines
• Basic knowledge of statistical approaches for safety data evaluation
• Familiarity with signal detection concepts and safety assessment methods
• Understanding of benefit-risk evaluation principles

DevelopingSkills

• Interest in learning biomarker and safety data interpretation
• Willingness to develop real-world evidence applications knowledge
• Growing ability to communicate safety information clearly
• Basic understanding of data presentation and visualization
• Interest in pharmacoepidemiology concepts

ProfessionalAttributes

• Strong communication skills for interacting with diverse teams
• Ability to work effectively under supervision while taking initiative
• Collaborative approach to cross-functional teamwork
• Understanding of the importance of balancing safety and development priorities
• Commitment to continuous learning and professional development

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.