Leads clinical safety and pharmacovigilance oversight for investigational and marketed products, with a strong emphasis on early development programs, signal detection, and safety strategy from first-in-human studies through global regulatory submissions. This role involves reviewing adverse event data, preparing safety outputs for IND/NDA/MAA filings, and helping shape risk management plans, product labeling, and clinical trial safety monitoring. The position works closely with early development, regulatory, and cross-functional teams in a global pharmaceutical setting and also mentors other safety staff.
Key Responsibilities
- Conduct safety surveillance and medical review of adverse events across assigned development and marketed products.
- Provide signal detection leadership, including trend analysis, risk assessment, and maintenance of the signal detection process and plan.
- Collaborate with early development teams on protocol design, dose escalation, and first-in-human safety assessments.
- Prepare and review safety deliverables for global submissions, including INDs, NDAs, MAAs, PSURs, and related documents.
- Review protocols, case report forms, investigator brochures, package inserts, patient narratives, and clinical study safety reports.
- Coordinate safety monitoring and spontaneous reporting as product/medical monitor for assigned programs.
- Represent CS&PV in interdepartmental, labeling, executive, and external partner or investigator discussions on safety issues.
- Mentor safety staff and contribute to SOPs, training, and departmental process improvement.
Required
- MD degree with a current US medical license.
- At least 5-7 years of experience in safety/pharmacovigilance within the pharmaceutical industry.
- Strong knowledge of FDA and global pharmacovigilance regulations, GCP, and ICH guidelines.
- Experience preparing and reviewing safety content for global regulatory filings.
- Experience working in a global pharmaceutical environment.
Preferred
- Experience with both development-stage and post-marketing products.
- Direct experience in early development safety monitoring and safety strategy.
- Experience interacting with global regulatory authorities.
- Experience serving in a senior or lead safety role.
Benefits & Perks
- Competitive base salary with incentive opportunity.
- Comprehensive medical, dental, vision, and prescription drug coverage.
- Company-provided basic life, accidental death & dismemberment, short-term disability, and long-term disability insurance.
- Tuition reimbursement and student loan assistance.
- Generous 401(k) match.
- Flexible time off, paid holidays, and paid leave programs.