Vera Therapeutics, Inc. · 3 hours ago

Director, Pharmacovigilance Scientist

United States

Full-time

Remote

Director/Executive

10+ years exp

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Responsibilities

Directly responsible for all aspects of Pharmacovigilance activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.)

Leads along with Pharmacovigilance Physician the Medical Safety Review Committee (MSRC) and Medical Safety Review Board (MSRB) meetings and related activities.

Represent DSPV for assigned compounds on cross-functional teams, Independent Data Monitoring Committees (IDMC).

Along with Pharmacovigilance Physician, proactively identify and develop safety strategies and planning for compound and non-compound specific Pharmacovigilance activities.

Medically review ICSRs, and other data sources of assigned compounds.

Actively participate in the development and maintenance of relevant SOPs, working practices and guides.

Work to continuously improve DSPV, including cultivating cross functional relationships and mentoring junior safety scientists.

Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.

Function as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest.

A proven ability to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.

An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities.

Participate in review of Protocols, CSRs, ICF’s, CTD’s, IB’s.

Ability to utilize ARGUS safety database for purposes of medical case review, analysis and simple queries.

Qualification

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PharmacovigilanceDrug SafetyMedical OversightSignal ManagementSafety SurveillanceBenefit Risk AssessmentClinical DevelopmentNephrology ExperienceRegulatory CompliancePharmD DegreeMD DegreeARGUS DatabaseClinical ResearchAudit ParticipationCross-Functional Collaboration

Required

10+ years of total relevant experience in PV and/or relevant medical field or equivalent of industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content).

5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree required.

A proven ability to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.

An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities.

Ability to utilize ARGUS safety database for purposes of medical case review, analysis and simple queries.

Preferred

Clinical experience and/or industry experience in nephrology and antibodies is a plus.

Experience participating in audits/inspections as Subject Matter Expert (SME) and mentor for colleagues/direct reports in audit/inspection preparedness and participation.