BioSpace
Director, Pharmacovigilance - San Diego, CA
BioSpace, San Diego, California, United States, 92189
Position Summary
Mirador is a next‑generation precision medicine company focused on immunology and inflammation. The company’s Mirador360™ precision development engine leverages advances in human genetics and data science to rapidly advance new precision medicines for patients with chronic immune‑mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life‑sciences investors and is based in San Diego, CA. As Director, Pharmacovigilance (PV), you will lead and oversee safety reporting activities across clinical programs, with a primary focus on managing and coordinating pharmacovigilance deliverables with contract research organizations (CROs). This role ensures compliance with global regulatory requirements, company SOPs, and high‑quality execution of safety reporting obligations. You will act as the key liaison between internal stakeholders and CRO partners to drive operational excellence and regulatory compliance. Responsibilities
Oversee all safety reporting activities managed by CROs, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs). Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations. Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs. Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators. Lead safety reporting governance, including escalation of significant safety issues, compliance deviations, and regulatory queries. Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance. Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs. Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness. Support development and maintenance of internal PV policies, SOPs, and training programs. Participate in safety signal detection activities and safety governance committees, as needed. Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events. Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations. Qualifications
Bachelor’s degree; advanced degree a plus. 10 + years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role. Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting. Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements. Experience overseeing drug safety databases (e.g., Oracle Argus). Proven track record of ensuring compliance in a global PV environment. Skills & Abilities
Strong interpersonal and relationship‑building skills across all levels; adept at leading and motivating cross‑functional matrixed teams. Self‑motivated with an entrepreneurial mindset, sense of urgency, and flexibility to learn new therapeutic areas. Analytical and problem‑solving skills; risk identification, management, and innovative thinking. Scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders. Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity. Excellent communication, negotiation, and leadership skills. Compensation
The expected base pay range for this position is $195,000 – $220,000, plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position; individual pay will be determined by additional factors such as job‑related skills, experience, and relevant education or training. EEO Statement
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected class.
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Mirador is a next‑generation precision medicine company focused on immunology and inflammation. The company’s Mirador360™ precision development engine leverages advances in human genetics and data science to rapidly advance new precision medicines for patients with chronic immune‑mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life‑sciences investors and is based in San Diego, CA. As Director, Pharmacovigilance (PV), you will lead and oversee safety reporting activities across clinical programs, with a primary focus on managing and coordinating pharmacovigilance deliverables with contract research organizations (CROs). This role ensures compliance with global regulatory requirements, company SOPs, and high‑quality execution of safety reporting obligations. You will act as the key liaison between internal stakeholders and CRO partners to drive operational excellence and regulatory compliance. Responsibilities
Oversee all safety reporting activities managed by CROs, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs). Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations. Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs. Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators. Lead safety reporting governance, including escalation of significant safety issues, compliance deviations, and regulatory queries. Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance. Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs. Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness. Support development and maintenance of internal PV policies, SOPs, and training programs. Participate in safety signal detection activities and safety governance committees, as needed. Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events. Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations. Qualifications
Bachelor’s degree; advanced degree a plus. 10 + years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role. Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting. Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements. Experience overseeing drug safety databases (e.g., Oracle Argus). Proven track record of ensuring compliance in a global PV environment. Skills & Abilities
Strong interpersonal and relationship‑building skills across all levels; adept at leading and motivating cross‑functional matrixed teams. Self‑motivated with an entrepreneurial mindset, sense of urgency, and flexibility to learn new therapeutic areas. Analytical and problem‑solving skills; risk identification, management, and innovative thinking. Scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders. Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity. Excellent communication, negotiation, and leadership skills. Compensation
The expected base pay range for this position is $195,000 – $220,000, plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position; individual pay will be determined by additional factors such as job‑related skills, experience, and relevant education or training. EEO Statement
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected class.
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