Associate Director, Drug Safety Physician
Rigel Pharmaceuticals Inc.
September 02, 2026
Remote friendly (South San Francisco, CA)
United States
Medical Affairs
Responsibilities:
- Perform comprehensive medical review of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources.
- Assess adverse event clinical significance, seriousness, expectedness, and causality; provide medical causality assessment for SAEs and SUSARs.
- Review medical narratives and ensure medical accuracy/consistency of case documentation; analyze similar cases and perform case series evaluations to support signal detection and regulatory decision-making.
- Provide medical guidance to case processing teams and ensure compliance with global pharmacovigilance regulations.
- Review aggregate safety data in standardized regulatory reports (e.g., Investigator Brochures, DSURs, PBRERs, PSURs) to identify potential medicinal product risks.
- Ensure MedDRA and WHO-DD coding appropriateness with CRO DSPV staff.
- Coordinate submission/distribution of expedited and periodic safety reports to regulators and partners.
- Oversee setup of new safety projects (Safety Management Plan and study safety systems/processes).
- Lead safety data analysis and signal management; conduct advanced signal detection using preclinical/clinical/literature data.
- Author/review safety sections of IND Annual Reports, PADERs, DSURs, PSURs, integrated safety summaries, and related submissions; support biomarker-driven safety considerations.
- Lead department operations, training, service provider oversight, and regulatory audit preparations; develop policies/business strategies for multi-jurisdiction compliance.
- Serve as cross-functional liaison and represent Drug Safety in clinical team meetings.
Qualifications & Skills:
- MD (or equivalent) required.
- 8–12 years progressive drug safety/pharmacovigilance experience in biopharma; 3–4 years leadership with safety team management.
- Expertise in oncology drug development, precision medicine/biomarkers, novel modalities (e.g., targeted therapies, ADCs).
- Deep knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, GVP) and safety signal detection/benefit-risk.
- Experience integrating biomarker data into safety monitoring/risk management; regulatory submission experience for complex oncology products.
- Excellent written/verbal communication; ability to influence cross-functional stakeholders; interface with regulators.
Benefits:
- Eligible for annual bonus and equity incentive awards (subject to plan terms).
- Comprehensive benefits: medical/dental/vision, life/disability insurance, flexible spending accounts, 401(k), paid time off, paid holidays.
- Perform comprehensive medical review of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources.
- Assess adverse event clinical significance, seriousness, expectedness, and causality; provide medical causality assessment for SAEs and SUSARs.
- Review medical narratives and ensure medical accuracy/consistency of case documentation; analyze similar cases and perform case series evaluations to support signal detection and regulatory decision-making.
- Provide medical guidance to case processing teams and ensure compliance with global pharmacovigilance regulations.
- Review aggregate safety data in standardized regulatory reports (e.g., Investigator Brochures, DSURs, PBRERs, PSURs) to identify potential medicinal product risks.
- Ensure MedDRA and WHO-DD coding appropriateness with CRO DSPV staff.
- Coordinate submission/distribution of expedited and periodic safety reports to regulators and partners.
- Oversee setup of new safety projects (Safety Management Plan and study safety systems/processes).
- Lead safety data analysis and signal management; conduct advanced signal detection using preclinical/clinical/literature data.
- Author/review safety sections of IND Annual Reports, PADERs, DSURs, PSURs, integrated safety summaries, and related submissions; support biomarker-driven safety considerations.
- Lead department operations, training, service provider oversight, and regulatory audit preparations; develop policies/business strategies for multi-jurisdiction compliance.
- Serve as cross-functional liaison and represent Drug Safety in clinical team meetings.
Qualifications & Skills:
- MD (or equivalent) required.
- 8–12 years progressive drug safety/pharmacovigilance experience in biopharma; 3–4 years leadership with safety team management.
- Expertise in oncology drug development, precision medicine/biomarkers, novel modalities (e.g., targeted therapies, ADCs).
- Deep knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, GVP) and safety signal detection/benefit-risk.
- Experience integrating biomarker data into safety monitoring/risk management; regulatory submission experience for complex oncology products.
- Excellent written/verbal communication; ability to influence cross-functional stakeholders; interface with regulators.
Benefits:
- Eligible for annual bonus and equity incentive awards (subject to plan terms).
- Comprehensive benefits: medical/dental/vision, life/disability insurance, flexible spending accounts, 401(k), paid time off, paid holidays.