Senior Vice President, Drug Safety and Pharmacovigilance Mirum PharmaceuticalsSenior Vice President, Drug Safety and PharmacovigilanceFoster City, CaliforniaThe SVP leads the department and also works collaboratively across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system. Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects.
Medical Director, Drug Safety and Pharmacovigilance Ideaya Biosciences IncMedical Director, Drug Safety and PharmacovigilanceSouth San Francisco, CA$268,000–$331,000 / yearThe final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. Along with our inspiring mission, and highly collaborative and inclusive environment, 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).
Pharmacovigilance / Drug Safety Associate Sutro Biopharma, Inc.Pharmacovigilance / Drug Safety AssociateSouth San Francisco, CA$125,000–$150,000 / yearSutro is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation. The individual will gain broad exposure to clinical safety activities and work closely with experienced colleagues across Clinical Development and other functions while helping establish the systems and processes needed to support Sutro's development programs globally.
Director, Drug Safety and Pharmacovigilance Annexon IncDirector, Drug Safety and PharmacovigilanceSan Francisco, CARemote$292,000–$315,000 / yearAuthors, reviews and provides input as applicable for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator's Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI). Lead the analysis, identification and reporting or possible trends and concerns regarding compounds and key related products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
Director, Drug Safety & Pharmacovigilance Xencor IncDirector, Drug Safety & PharmacovigilanceSan Diego, CARemote$206,000–$255,000 / yearProvides end to end Drug Safety/PV support for assigned products including study start up activities, vendor plans, signal detection plans, SAE review, aggregate data review, signaling, aggregate authoring including DSURs, annual core product document updates (IB, ICF), and CSR authoring as well as informed consent forms, integrated summaries of safety, marketing applications and other regulatory submission documents on assigned products. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions.
NewDirector, Drug Safety & Pharmacovigilance Operations Rigel Pharmaceuticals IncDirector, Drug Safety & Pharmacovigilance OperationsSouth San Francisco, CA$210,000–$250,000 / yearProvide operational leadership and ensure cross-functional delivery of aggregate and summary safety reports, including IND Annual Reports, DSURs, PSURs/PBRERs, PADERs, integrated safety summaries, and related safety sections of protocols, CSRs, and regulatory submissions. Serve as business owner or senior operational lead for the safety database and related systems; define the roadmap and govern access, configuration changes, controlled terminology, data outputs, upgrades, validation/UAT, and vendor-hosted environments, as applicable.
Senior Vice President, Drug Safety and Pharmacovigilance Mirum Pharmaceuticals IncSenior Vice President, Drug Safety and PharmacovigilanceFoster City, CAThe SVP leads the department and also works collaboratively across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system. Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects.
Senior Vice President, Drug Safety And Pharmacovigilance Mirum Pharmaceuticals IncSenior Vice President, Drug Safety And PharmacovigilanceFoster City, CAThe SVP leads the department and also works collaboratively across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system. Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects.
Senior Director, Drug Safety And Pharmacovigilance Annexon, Inc.Senior Director, Drug Safety And PharmacovigilanceSan Francisco, CARemote$300,000–$375,000 / yearAuthors, reviews and provides input as applicable for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator's Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI). Lead the analysis, identification and reporting or possible trends and concerns regarding compounds and key related products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
Director, Drug Safety & Pharmacovigilance Xencor, Inc.Director, Drug Safety & PharmacovigilanceSan Diego, CARemote$206,000–$255,000 / yearThorough understanding of the drug development process in relation to safety surveillance activities in clinical trialsAbility to establish effective working relationships with people in a wide variety of disciplines and backgroundsAbility to manage and prioritize multiple projects and demands simultaneously, rapidly adjust to changing priorities, and work effectively under pressureKnowledge and understanding of all relevant global PV regulations, FDA, EU and ICH guidelines, initiatives and regulations governing clinical trial safety environmentsFamiliarity with Argus safety databaseKnowledge and training on MedDRA dictionary with relevance to adverse event codingExcellent interpersonal skills and professionalismExcellent time management and organizational skillsStrong analytical, assessment and problem-solving skillsAbility to read, analyze and interpret complex clinical data and informationAbility to demonstrate competencies applicable for job based on Xencor's Leadership Competency ModelAbility to effectively manage others through coaching and supervision, in accordance with company policies and practices. Reviews and provides safety functional input for development of protocols, IBs, ICFs, CSRs and other relevant study documentsActs as lead author for aggregate safety reports (e.g., DSURs)Leads efforts related to ad hoc and routine signal evaluationProvides Drug Safety/PV subject matter expertise on cross-functional platforms and teams throughout the companyProvides end to end Drug Safety/PV support for assigned products including study start up activities, vendor plans, signal detection plans, SAE review, aggregate data review, signaling, aggregate authoring including DSURs, annual core product document updates (IB, ICF), and CSR authoring as well as informed consent forms, integrated summaries of safety, marketing applications and other regulatory submission documents on assigned products.
Associate Director, Drug Safety Physician Rigel Pharmaceuticals, Inc.Associate Director, Drug Safety PhysicianSouth San Francisco, CA$210,000–$250,000 / yearExpert Safety Data Analysis & Signal Management Lead evaluation of complex drug safety data to identify safety signals and evaluate signals for evidence of causal association with precision oncology products, applying advanced analytical techniques and clinical judgment. Cross-Functional Leadership & Stakeholder Management Serve as primary liaison with therapeutic leads, safety physicians, biostatisticians, and key stakeholders on critical projects requiring advanced safety expertise.
Remote Pharmacovigilance / Drug Safety Pharmacist Pharmacy CareersRemote Pharmacovigilance / Drug Safety PharmacistFontana, CaliforniaRemoteRemote Pharmacovigilance Pharmacist – Drug Safety From Home | No Prior Pharma Experience Required Contribute to global patient safety by collecting, evaluating, and documenting adverse events — entirely from home. This role is open to pharmacists from hospital, ambulatory, community, or managed care backgrounds who have strong attention to detail and want to enter the pharmaceutical industry.
Senior Director of Drug Safety XtalPi IncSenior Director of Drug SafetySan Diego, CAWorking at the interface of computational design, translational biology and preclinical development, you will integrate mechanistic toxicology, pharmacology, DMPK and emerging clinical insights to enable informed, data-driven programme decisions and successful human translation. Reporting to the VP, Head of In Vivo Bioscience, the role will shape nonclinical and translational safety strategies supporting the progression of novel biologics, multi-specific antibodies and peptide therapeutics from discovery through early clinical development.
Associate Medical Director / Medical Director Arrowhead PharmaceuticalsAssociate Medical Director / Medical DirectorLos Angeles, CA$275,000–$310,000 / yearArrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
Associate Director, Medical Safety Science (Safety Scientist) Mirum PharmaceuticalsAssociate Director, Medical Safety Science (Safety Scientist)Foster City, California$215,000–$230,000 / yearThe ideal candidate will have experience in and perform multiple activities related to safety data review, document review, signal detection and management, authoring of aggregate reports and participating in multidisciplinary meetings. Minimum 7 years in pharmaceutical or CRO experience in clinical trial or post-market setting, 5 years in a drug safety and pharmacovigilance role (specifically, as a Safety Scientist).
Associate Director, Drug Substance Manufacturing - Downstream Process Vera Therapeutics IncAssociate Director, Drug Substance Manufacturing - Downstream ProcessBrisbane, CA$175,000–$210,000 / yearWorking with the CMC team and other key functions such as project management, QA and Regulatory, the ideal candidate must be an outstanding leader with a proven track record of overseeing all drug-substance downstream manufacturing activities at the CMO site, including process scale-up, technology transfers, validations, PPQ campaign support, continuous process improvements, and post-approval lifecycle management of commercially approved products. The individual will serve as a subject matter expert (SME) in downstream processes for outsourced drug-substance manufacturing, technology transfer, life cycle management, and global regulatory submissions of complex Biologics, monoclonal antibodies, and other recombinant therapeutics.
Associate Director, Drug Substance Manufacturing - Upstream Process Vera Therapeutics IncAssociate Director, Drug Substance Manufacturing - Upstream ProcessBrisbane, CA$175,000–$210,000 / yearWorking with the CMC team and other key functions such as project management, QA and Regulatory, the ideal candidate must be an outstanding leader with a proven track record of overseeing all drug-substance upstream manufacturing activities at the CMO site, including process scale-up, technology transfers, validations, PPQ campaign support, continuous process improvements, and post-approval lifecycle management of commercially approved products. The individual will serve as a subject matter expert (SME) in upstream processes for outsourced drug-substance manufacturing, technology transfer, life cycle management, and global regulatory submissions of complex Biologics, monoclonal antibodies, and other recombinant therapeutics.
Associate Director, Medical Safety Science (Safety Scientist) Mirum Pharmaceuticals IncAssociate Director, Medical Safety Science (Safety Scientist)Foster City, CA$215,000–$230,000 / yearThe ideal candidate will have experience in and perform multiple activities related to safety data review, document review, signal detection and management, authoring of aggregate reports and participating in multidisciplinary meetings. Minimum 7 years in pharmaceutical or CRO experience in clinical trial or post-market setting, 5 years in a drug safety and pharmacovigilance role (specifically, as a Safety Scientist).
Associate Director, Medical Safety Science Safety Scientist Mirum Pharmaceuticals IncAssociate Director, Medical Safety Science Safety ScientistFoster City, CA$215,000–$230,000 / yearThe ideal candidate will have experience in and perform multiple activities related to safety data review, document review, signal detection and management, authoring of aggregate reports and participating in multidisciplinary meetings. Minimum 7 years in pharmaceutical or CRO experience in clinical trial or post-market setting, 5 years in a drug safety and pharmacovigilance role (specifically, as a Safety Scientist).
Senior Drug Discovery Scientist AxiomSenior Drug Discovery ScientistSan Francisco, CaliforniaThis creates a compounding loop: deeper customer understanding shapes the data we generate; better data improves frontier models, Axiom’s fine-tuned models, and our agentic infrastructure; stronger models and tooling expand the capabilities we can offer; and those capabilities are forward deployed into pharma's drug discovery workflows, where scientists use them to solve the highest value drug discovery problems. Partner directly with drug hunters at top pharma companies, researchers at leading AI labs, and Axiom’s multidisciplinary team to build the experimental datasets and agentic systems needed to accurately predict human outcomes, then deploy those systems into real discovery workflows to inform major go/no-go decisions across high-value drug programs.