Associate Director, Safety Operations
Olema Oncology
Full-time
Remote friendly (Cambridge, MA)
United States
Operations
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Role Summary
Associate Director, Safety Operations. Responsible for overseeing daily operations of the Safety team, solving complex project management issues, and managing safety reporting compliance. Role may be based in San Francisco, CA or Boston, MA with 5% travel.
Responsibilities
- Ensuring timely and accurate processing of safety reporting to regulatory authorities, investigators, ethics committees, and business partners within timelines and SOPs
- Managing safety reporting compliance
- Drafting and reviewing pharmacovigilance documents
- Preparing metrics related to safety reporting and reporting to upper management
- Collaborating with Clinical Operations, Data Management, and Biostatistics; participating in meetings with cross-functional teams, CROs, and business partners
- Managing vendors, audit and inspection readiness, and implementation; overseeing pre-launch, pre-commercial, and commercial launch safety operations
- Assisting with study start-up and management of new/future studies
- Spearheading development of departmental systems including SOPs and guidelines
- Performing SAE Reconciliation
- Training internal and external groups in Pharmacovigilance principles and best practices
- Working with safety vendor on daily operations tasks and implementing key action items
Qualifications
- Required: BA/BS in life sciences, pharmacy, nursing, or related field; 7–10 years in the pharmaceutical industry with at least 5 years in safety
- Preferred: Broad clinical/medical knowledge, pharmacovigilance expertise, and technical system proficiency
- Strong understanding of global pharmacovigilance regulations, clinical trial methodology, and Good Clinical Practices (GCP)
- Excellent presentation, communication, and interpersonal skills; strong written and verbal communication
- Experience managing external vendors and ensuring audit/inspection readiness; pre-commercial and launch readiness
- Strong organizational, project management, technical, and problem-solving skills
Skills
- Independent work style with initiative and flexibility
- Process and system improvement mindset in drug safety
- Maintaining confidentiality and ethical standards
- Cross-functional collaboration and clear written/verbal communication
Education
- BA/BS in life sciences, pharmacy, nursing, or related field
Additional Requirements
- Travel: 5% travel
- Location: San Francisco, CA or Boston, MA