Director - Pharmacovigilance Scientist
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Title: Director, Pharmacovigilance Scientist
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
The Director, Pharmacovigilance Scientist will report to the Executive Director, PV Operations & PV Science and will be responsible for providing Medical oversight for the global drug safety and pharmacovigilance function as it relates to SAEs, AE’s, Lab’s, Safety Surveillance to ensure proactive and timely review and assessment of all safety data, related to our portfolio of therapies. Working with all members of Drug safety & Pharmacovigilance, Clinical Operations, Clinical Research and Medical Affairs teams, this role will provide strategic and tactical leadership and oversee all aspects of Medical Safety Science activities through all stages of clinical development as well as post-marketing patient safety.
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.
Qualifications:
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.
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.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is starting at $225,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.
About the job
Director - Pharmacovigilance Scientist
To see similar active jobs please follow this link: Remote Management jobs
Title: Director, Pharmacovigilance Scientist
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
The Director, Pharmacovigilance Scientist will report to the Executive Director, PV Operations & PV Science and will be responsible for providing Medical oversight for the global drug safety and pharmacovigilance function as it relates to SAEs, AE’s, Lab’s, Safety Surveillance to ensure proactive and timely review and assessment of all safety data, related to our portfolio of therapies. Working with all members of Drug safety & Pharmacovigilance, Clinical Operations, Clinical Research and Medical Affairs teams, this role will provide strategic and tactical leadership and oversee all aspects of Medical Safety Science activities through all stages of clinical development as well as post-marketing patient safety.
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.
Qualifications:
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.
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.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is starting at $225,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.