Drug Safety Physician ~ Onsite
Nurix Therapeutics
21 days ago
On-site
Brisbane, CA
Medical Affairs
Position: Drug Safety Physician
Responsibilities:
- Serve as the medical safety lead for assigned products; provide clinical and pharmacovigilance expertise to safety strategy and activities.
- Lead aggregate safety data analysis for signal detection, signal evaluation, and risk characterization.
- Conduct medical review and interpretation of safety data to support benefit–risk assessments.
- Monitor emerging safety signals and proactively address potential safety risks via internal and external communication.
- Contribute to safety responses to regulatory authorities and participate in regulatory interactions.
- Provide clinical leadership during inspections and audits related to safety and risk management.
- Author and review regulatory safety documents, including DSURs; safety sections of INDs; and regulatory briefing books.
- Provide clinical input into safety aspects of clinical trial protocols, informed consent forms, and investigator brochures.
- Collaborate to ensure a consistent global safety strategy.
- Serve on safety governance committees to support risk mitigation and benefit–risk evaluation.
Requirements:
- Medical degree (required).
- Clinical experience (preferred).
- 10+ years in pharmacovigilance/drug safety (pharma/biotech).
- Demonstrated expertise in aggregate safety analysis and benefit–risk evaluation.
- Strong knowledge of global pharmacovigilance regulations/guidance (ICH, FDA, EMA, MHRA).
- Experience with early/late-stage development, regulatory submissions, and product launch.
- Experience in post-marketing safety surveillance and risk management.
- Experience interacting with global health authorities on safety matters.
- Familiarity with signal detection and safety surveillance tools/databases.
- Strong communication, collaboration, cross-functional leadership.
- Ability to interpret complex clinical/safety data and translate insights to regulatory/business strategy.
- Onsite in Brisbane, CA.
Compensation:
- Salary range: $307K–$351K plus bonus & equity.
Responsibilities:
- Serve as the medical safety lead for assigned products; provide clinical and pharmacovigilance expertise to safety strategy and activities.
- Lead aggregate safety data analysis for signal detection, signal evaluation, and risk characterization.
- Conduct medical review and interpretation of safety data to support benefit–risk assessments.
- Monitor emerging safety signals and proactively address potential safety risks via internal and external communication.
- Contribute to safety responses to regulatory authorities and participate in regulatory interactions.
- Provide clinical leadership during inspections and audits related to safety and risk management.
- Author and review regulatory safety documents, including DSURs; safety sections of INDs; and regulatory briefing books.
- Provide clinical input into safety aspects of clinical trial protocols, informed consent forms, and investigator brochures.
- Collaborate to ensure a consistent global safety strategy.
- Serve on safety governance committees to support risk mitigation and benefit–risk evaluation.
Requirements:
- Medical degree (required).
- Clinical experience (preferred).
- 10+ years in pharmacovigilance/drug safety (pharma/biotech).
- Demonstrated expertise in aggregate safety analysis and benefit–risk evaluation.
- Strong knowledge of global pharmacovigilance regulations/guidance (ICH, FDA, EMA, MHRA).
- Experience with early/late-stage development, regulatory submissions, and product launch.
- Experience in post-marketing safety surveillance and risk management.
- Experience interacting with global health authorities on safety matters.
- Familiarity with signal detection and safety surveillance tools/databases.
- Strong communication, collaboration, cross-functional leadership.
- Ability to interpret complex clinical/safety data and translate insights to regulatory/business strategy.
- Onsite in Brisbane, CA.
Compensation:
- Salary range: $307K–$351K plus bonus & equity.