BioSpace
Senior Medical Director, Patient Safety & Pharmacovigilance
BioSpace, South San Francisco, California, us, 94083
Overview
Join to apply for the
Director, Safety Science
role at
IDEAYA Biosciences . Location: South San Francisco or San Diego, CA. Onsite four days per week per our company policy. What you’ll do
Report directly to the Vice President of Drug Safety and indirectly to the Senior Medical Director of Drug Safety. Lead safety monitoring for investigational and marketed products, ensuring alignment with corporate development strategies. Oversee core safety deliverables, including safety governance, signal detection/management, periodic/aggregate reporting, and case processing. Supervise and mentor all safety scientists, fostering a collaborative and high-performing team. Conduct safety analyses using case series, data summaries, adverse event trends, and clinical/post-marketing data. Review medical and scientific literature for signal detection and aggregate reporting. Develop and maintain product-specific Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Perform safety data monitoring, interpretation, and analysis. Lead the preparation of safety deliverables, including integrated safety reports and regulatory documents (e.g., PBRER/PSUR, DSUR, PADERs). Provide safety input to clinical documents such as Investigator’s Brochures, study protocols, and clinical study reports. Ensure consistency in safety and risk management content across regulatory submissions. Partner with safety physicians and cross-functional teams on signal detection and risk management activities. Participate in safety governance meetings and contribute to benefit-risk assessments. Author and review safety sections for regulatory packages, including NDAs and responses to health authority queries. Support pharmacovigilance vendor oversight, process improvement initiatives, and inspections/audits. Maintain up-to-date expertise in disease areas, drug safety, regulatory trends, and business practices. Requirements
PharmD, RN, or MD required; advanced degrees (e.g., Master’s) preferred. At least 6 years of experience in patient safety and pharmacovigilance, including team management. More than 3 years of experience authoring and reviewing periodic/ad hoc safety reports and clinical documents (e.g., PSURs, DSURs, Clinical Overviews). Expertise in safety analyses, signal detection, risk management, and health authority responses. Experience with NDA/MAA filings. Strong ability to interpret and integrate safety data. Effective communication skills (written and verbal) for internal and external audiences. Proven leadership in mentoring and managing scientific teams. Must be authorized to work in the United States on a full-time basis. Total Rewards
Along with our inspiring mission, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs. The expected salary range for the role of Director, Safety Science, is $235,000-$290,000. The final salary offered will depend on factors including office location, candidate experience, disease area experience, education, and interview performance. The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants based on protected characteristics. This position requires onsite work in the company facilities for training and meetings, with work-from-home flexibility. All employees working in facilities must be fully vaccinated against COVID-19, subject to applicable law and reasonable accommodations. IDEAYA is an equal opportunity employer. EOE/AA/Vets.
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Join to apply for the
Director, Safety Science
role at
IDEAYA Biosciences . Location: South San Francisco or San Diego, CA. Onsite four days per week per our company policy. What you’ll do
Report directly to the Vice President of Drug Safety and indirectly to the Senior Medical Director of Drug Safety. Lead safety monitoring for investigational and marketed products, ensuring alignment with corporate development strategies. Oversee core safety deliverables, including safety governance, signal detection/management, periodic/aggregate reporting, and case processing. Supervise and mentor all safety scientists, fostering a collaborative and high-performing team. Conduct safety analyses using case series, data summaries, adverse event trends, and clinical/post-marketing data. Review medical and scientific literature for signal detection and aggregate reporting. Develop and maintain product-specific Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Perform safety data monitoring, interpretation, and analysis. Lead the preparation of safety deliverables, including integrated safety reports and regulatory documents (e.g., PBRER/PSUR, DSUR, PADERs). Provide safety input to clinical documents such as Investigator’s Brochures, study protocols, and clinical study reports. Ensure consistency in safety and risk management content across regulatory submissions. Partner with safety physicians and cross-functional teams on signal detection and risk management activities. Participate in safety governance meetings and contribute to benefit-risk assessments. Author and review safety sections for regulatory packages, including NDAs and responses to health authority queries. Support pharmacovigilance vendor oversight, process improvement initiatives, and inspections/audits. Maintain up-to-date expertise in disease areas, drug safety, regulatory trends, and business practices. Requirements
PharmD, RN, or MD required; advanced degrees (e.g., Master’s) preferred. At least 6 years of experience in patient safety and pharmacovigilance, including team management. More than 3 years of experience authoring and reviewing periodic/ad hoc safety reports and clinical documents (e.g., PSURs, DSURs, Clinical Overviews). Expertise in safety analyses, signal detection, risk management, and health authority responses. Experience with NDA/MAA filings. Strong ability to interpret and integrate safety data. Effective communication skills (written and verbal) for internal and external audiences. Proven leadership in mentoring and managing scientific teams. Must be authorized to work in the United States on a full-time basis. Total Rewards
Along with our inspiring mission, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs. The expected salary range for the role of Director, Safety Science, is $235,000-$290,000. The final salary offered will depend on factors including office location, candidate experience, disease area experience, education, and interview performance. The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants based on protected characteristics. This position requires onsite work in the company facilities for training and meetings, with work-from-home flexibility. All employees working in facilities must be fully vaccinated against COVID-19, subject to applicable law and reasonable accommodations. IDEAYA is an equal opportunity employer. EOE/AA/Vets.
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