Olema Oncology
Overview
Associate Director, Safety Sciences role at Olema Oncology. The role is based in San Francisco or Boston and requires
Responsibilities
Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment Perform signal evaluation for identified safety signals and author safety evaluation reports Manage preparation and completion of safety documents, including DSURs, PADERs/PBRERs, RMPs, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, and CCDS, etc. Participate in and/or lead responses to regulatory inquiries and other risk management activities Support clinical/medical review of SAEs, AESI, SUSARs, and AOSE, including reviewing source documents, case narratives, MedDRA coding, and preparing sponsor assessments; assist Safety Operations in determining reportability Conduct literature search activities and develop key search strings for review information Support and attend Data Monitoring Committee (DMC) meetings as required Support quality systems, inspection readiness, audits, and inspections Actively participate in process improvementInitiatives, including development and maintenance of relevant SOPs Collaborate with cross-functional teams and external stakeholders, including business partners and safety vendors/contractors Lead and facilitate safety team meetings with effective communication Apply relevant FDA, EU, and ICH guidelines governing pharmacovigilance activities Ideal Candidate Profile
Knowledge:
MD, PhD in medical/biological sciences, PharmD, or RN; experience in Small Molecule and Oncology is required. Experience:
5+ years (MD/PhD/PharmD) or 8+ years (RN) of pharmacovigilance/drug safety in biopharmaceutical industry; experience with SOPs and supporting documents; ability to apply FDA, EU, and ICH guidelines; experience working with business partners and safety vendors; familiarity with safety databases and ED C. Attributes:
Time management, prioritization, strong communication, analytical and problem-solving skills; self-motivated, fast learner, professional with sound judgment and ethics. Qualifications Summary
MD, PhD, PharmD, or RN degree with relevant pharmacovigilance experience Small Molecule and Oncology experience required 5+ years (MD/PhD/PharmD) or 8+ years (RN) pharmacovigilance/drug safety experience Experience with safety databases and MedDRA coding; experience mentoring junior team members Strong verbal and written communication; ability to convey safety findings clearly Compensation & Benefits
The base pay range for this position is expected to be
$195,000 - $210,000
annually, with the total compensation package including equity, bonus, and benefits. Pay may vary by location, experience, and qualifications. Important Information
Olema is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note: Olema does not accept agency resumes and is not responsible for fees related to unsolicited resumes. Fraud Alert: Olema’s official information and communications come from @olema.com domain; visit olema.com/careers for official listings.
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Associate Director, Safety Sciences role at Olema Oncology. The role is based in San Francisco or Boston and requires
Responsibilities
Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment Perform signal evaluation for identified safety signals and author safety evaluation reports Manage preparation and completion of safety documents, including DSURs, PADERs/PBRERs, RMPs, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, and CCDS, etc. Participate in and/or lead responses to regulatory inquiries and other risk management activities Support clinical/medical review of SAEs, AESI, SUSARs, and AOSE, including reviewing source documents, case narratives, MedDRA coding, and preparing sponsor assessments; assist Safety Operations in determining reportability Conduct literature search activities and develop key search strings for review information Support and attend Data Monitoring Committee (DMC) meetings as required Support quality systems, inspection readiness, audits, and inspections Actively participate in process improvementInitiatives, including development and maintenance of relevant SOPs Collaborate with cross-functional teams and external stakeholders, including business partners and safety vendors/contractors Lead and facilitate safety team meetings with effective communication Apply relevant FDA, EU, and ICH guidelines governing pharmacovigilance activities Ideal Candidate Profile
Knowledge:
MD, PhD in medical/biological sciences, PharmD, or RN; experience in Small Molecule and Oncology is required. Experience:
5+ years (MD/PhD/PharmD) or 8+ years (RN) of pharmacovigilance/drug safety in biopharmaceutical industry; experience with SOPs and supporting documents; ability to apply FDA, EU, and ICH guidelines; experience working with business partners and safety vendors; familiarity with safety databases and ED C. Attributes:
Time management, prioritization, strong communication, analytical and problem-solving skills; self-motivated, fast learner, professional with sound judgment and ethics. Qualifications Summary
MD, PhD, PharmD, or RN degree with relevant pharmacovigilance experience Small Molecule and Oncology experience required 5+ years (MD/PhD/PharmD) or 8+ years (RN) pharmacovigilance/drug safety experience Experience with safety databases and MedDRA coding; experience mentoring junior team members Strong verbal and written communication; ability to convey safety findings clearly Compensation & Benefits
The base pay range for this position is expected to be
$195,000 - $210,000
annually, with the total compensation package including equity, bonus, and benefits. Pay may vary by location, experience, and qualifications. Important Information
Olema is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note: Olema does not accept agency resumes and is not responsible for fees related to unsolicited resumes. Fraud Alert: Olema’s official information and communications come from @olema.com domain; visit olema.com/careers for official listings.
#J-18808-Ljbffr