Vice President - Pharmacovigilance
To see similar active jobs please follow this link: Remote Management jobs
Title: Vice President, Pharmacovigilance
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 Vice President, Pharmacovigilance will report to the Chief Medical Officer and will be responsible for providing medical oversight for the global drug safety and pharmacovigilance function to ensure proactive and timely benefit-risk assessments of all safety data, related to our portfolio of therapies. Working with the Clinical Research and Medical Affairs teams, this role will provide strategic and tactical leadership and oversee all aspects of Pharmacovigilance activities through all stages of clinical development as well as post-marketing patient safety.
Responsibilities:
Lead global clinical safety, pharmacovigilance and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline.
Build and manage a high-performing pharmacovigilance team by setting clear expectations & providing hands-on leadership, promoting collaboration and team cohesiveness.
Provide strategic oversight for safety sections of all regulatory documents, including BLA/MAA/NDA, public presentations and key scientific articles and abstracts.
Review trends in safety, including in the class of therapeutic, and provide insights as to any developments.
Advise Leadership on safety matters and provide strategies for addressing and informing on safety matters, including information provided to investors, patients, and physicians.
Ensure compliance with global pharmacovigilance regulations and guidelines.
Provide medical guidance and evaluation of all pre- and post-marketing safety data.
Collaborate cross-functionally and with key internal and external stakeholders, including clinical operations, clinical development, regulatory affairs, quality assurance, and medical affairs, senior management, regulatory agencies, alliance partners, investigators and KOLs.
Qualifications:
MD and Board Certification in a relevant therapeutic area.
10+ years of experience in pharmacovigilance leadership roles.
In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, EMA, and other relevant regulatory requirements.
Experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics.
Demonstrated understanding of current global safety regulatory reporting requirements for investigational and marketed products.
Experience mentoring all levels of staff to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters retention.
Demonstrated strong written and verbal communication skills.
Proven mindset of proactive continuous improvement.
Efficient independent worker with ability to focus and drive for results.
Ability to work in a fast paced-environment and to handle multiple tasks.
Strong commitment to ethical standards.
Ability to travel up to 20%.
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 $309,000 - $424,000. 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.
About the job
Vice President - Pharmacovigilance
To see similar active jobs please follow this link: Remote Management jobs
Title: Vice President, Pharmacovigilance
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 Vice President, Pharmacovigilance will report to the Chief Medical Officer and will be responsible for providing medical oversight for the global drug safety and pharmacovigilance function to ensure proactive and timely benefit-risk assessments of all safety data, related to our portfolio of therapies. Working with the Clinical Research and Medical Affairs teams, this role will provide strategic and tactical leadership and oversee all aspects of Pharmacovigilance activities through all stages of clinical development as well as post-marketing patient safety.
Responsibilities:
Lead global clinical safety, pharmacovigilance and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline.
Build and manage a high-performing pharmacovigilance team by setting clear expectations & providing hands-on leadership, promoting collaboration and team cohesiveness.
Provide strategic oversight for safety sections of all regulatory documents, including BLA/MAA/NDA, public presentations and key scientific articles and abstracts.
Review trends in safety, including in the class of therapeutic, and provide insights as to any developments.
Advise Leadership on safety matters and provide strategies for addressing and informing on safety matters, including information provided to investors, patients, and physicians.
Ensure compliance with global pharmacovigilance regulations and guidelines.
Provide medical guidance and evaluation of all pre- and post-marketing safety data.
Collaborate cross-functionally and with key internal and external stakeholders, including clinical operations, clinical development, regulatory affairs, quality assurance, and medical affairs, senior management, regulatory agencies, alliance partners, investigators and KOLs.
Qualifications:
MD and Board Certification in a relevant therapeutic area.
10+ years of experience in pharmacovigilance leadership roles.
In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, EMA, and other relevant regulatory requirements.
Experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics.
Demonstrated understanding of current global safety regulatory reporting requirements for investigational and marketed products.
Experience mentoring all levels of staff to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters retention.
Demonstrated strong written and verbal communication skills.
Proven mindset of proactive continuous improvement.
Efficient independent worker with ability to focus and drive for results.
Ability to work in a fast paced-environment and to handle multiple tasks.
Strong commitment to ethical standards.
Ability to travel up to 20%.
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 $309,000 - $424,000. 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.