Associate Director, Safety Operations
Olema Oncology
Full-time
Remote friendly (San Francisco, CA)
United States
Operations
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Role Summary
Associate Director, Safety Operations — Oversight of daily safety team operations, regulatory safety reporting, and pharmacovigilance processes. 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 as needed
- 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, pre-launch activities, pre-commercial and commercial launch, and NDA safety operations
- Assisting with study start up and management of new/future studies
- Spearheading development of departmental systems including SOPs and departmental guidelines
- Performing SAE reconciliation
- Training internal and external groups in pharmacovigilance principles and best practices
- Working with safety vendor for daily operations tasks and implementing key action items
Qualifications
- Required: BA/BS degree in life sciences, pharmacy, nursing, or related field; 7-10 years of pharmaceutical industry experience, with at least 5 years in safety; strong understanding of pharmacovigilance regulations and GCP
- Preferred: Experience with drug safety databases; external vendor management; audit and inspection readiness; pre-commercial and commercial launch experience
Skills
- Strong organizational, project management, technical, and problem-solving abilities
- Excellent presentation, communication, and interpersonal skills; strong written and verbal communication
- Ability to work independently, demonstrate initiative and flexibility; cross-functional collaboration
Education
- BA/BS in life sciences, pharmacy, nursing, or related discipline
Additional Requirements
- 5% travel; role may be based in SF, CA or Boston, MA