Associate Medical Director, Safety Science
3 Days Old
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
Developing Skills
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
Professional Attributes
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.
The salary range for this position is: $172,800 to $259,200. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
- Location:
- San Rafael, CA, United States
- Category:
- Management Occupations