Provides medical oversight for drug safety and pharmacovigilance activities in clinical development, with a focus on adverse event review, ongoing safety surveillance, and emerging safety issues across oncology and hematology programs. The role also supports aggregate safety reporting, clinical and regulatory deliverables, and inspection readiness in a cross-functional biotech environment.
Key Responsibilities
- Conduct medical review of adverse event reports for company products.
- Provide ongoing surveillance of safety data from clinical trials.
- Review and contribute to trial protocols, amendments, reports, plans, CRFs, informed consent documents, Investigator’s Brochures, and related clinical materials.
- Prepare aggregate reports and safety summaries in accordance with regulatory requirements.
- Establish and manage external Data Monitoring Committees and chair internal safety committees.
- Conduct training for employees, CROs, and investigators on safety and pharmacovigilance topics.
- Collaborate with clinical, safety, and regulatory teams, including CROs and external partners.
- Ensure compliance with regulatory guidelines and internal procedures and participate in audit and inspection activities as needed.
Required
- Medical degree (MD or equivalent) with relevant clinical experience.
- At least 8 years of experience in pharmacovigilance, drug safety, or clinical development within the pharmaceutical or biotechnology industry.
- Experience with adverse event medical review, safety surveillance, signal evaluation, benefit-risk assessment, and aggregate safety reporting.
- Experience supporting clinical trial safety deliverables and regulatory documentation.
- Strong knowledge of global pharmacovigilance and clinical development requirements, including FDA, EMA, PMDA, and ICH expectations.
- Experience supporting safety committees, DMCs, regulatory submissions, audits, and inspections.
Preferred
- Oncology or hematology experience.
- Experience working in pharmaceutical or biotechnology clinical development.
- Experience guiding team members through complex safety and regulatory issues.
Benefits & Perks
- Eligible U.S. compensation range of $200,000 to $300,000, with potential bonus and long-term incentive eligibility.
- 401(k) plan with 100% match on the first 6% of contributions for eligible U.S. employees.
- Medical, dental, and vision insurance options, including an HDHP with HSA.
- Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave.
- Backup care, family support programs, financial wellness tools, and emotional well-being support.
- Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account.