Vera Therapeutics, Inc.
Senior Manager, Pharmacovigilance Operations
Vera Therapeutics, Inc., Brisbane, California, United States, 94005
Senior Manager, Pharmacovigilance Operations
Brisbane, CA Vera Therapeutics (Nasdaq: VERA), is a late clinical-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 fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and 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. Responsibilities
Ensure standards for collection and processing of ICSR, including alignment with GDPR requirements. Oversee development of global SOPs and policies to ensure compliance with regional PV regulatory requirements and to drive improvements in Vera global PV processes. Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, key performance metrics, and monitoring of performance and compliance, and training at a global level. Liaise with Vendor PV Systems team to ensure case processing SOPs and tools contain guidance to allow for timely and accurate submissions to global health authorities, partners, etc. Lead PV relationships with PV vendor(s) and ensure compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs). Oversee Post Marketed PV operations. Direct relationship with and output of vendor(s) in accordance with SOPs. Liaises VP of DSPV, financial / project management for budget planning. Approve invoices and confirm accuracy of spend and bills. Lead case processing teams to assess / predict case volumes to ensure staffing planning at vendor. Direct planning for ad-hoc case processing related projects e.g. Legal cases. Lead and facilitate regular joint operating committee meetings to review / address issues if needed for
Adherence to KPIs and Vera Standards Forecast demand Issue escalations Continuous improvement initiatives Change management
Manage / review delivery against MSA terms. Monitor global KPIs. Ensure quality of deliverables across teams. Represent voice of vendor to PV function. Provide guidance to delivery teams. Maintain operating procedures (describing operating rules with vendor). Lead change management and ongoing training. Establish and manage vendor oversight procedures. Partner with DSPV Compliance and QA teams to establish and manage vendor quality agreement procedures. Drive preparedness for regulatory authority inspection and internal audits for PV operational activities for Vera; participate in audits/inspections as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/inspection preparedness and participation. Qualifications
A minimum of a bachelor’s degree in a health/biomedical or related field, OR Registered Nurse, Licensed Practical Nurse, or Pharmacist with current certification/licensure (e.g., LPN, RN, RPh, PharmD) required. A minimum of 5 years of pharmaceutical or health care related industry experience required. Minimum 5 years PV experience with 3 years experience working with CROs, vendors, and relationship management preferred. Must have significant PV experience including experience working with CROs, vendors, and relationship management. Must have experience in Global PV inspections which include serving as an SME with direct contact with inspectors. Must have experience in preparing written responses from inspection findings, completing CAPA and implementing efficacy checks. Good cross cultural and cross functional understanding and experience, and ability to liaise with relevant teams/departments such as medical information, regulatory, affiliate relations. Experience in people management and well developed skills in teambuilding, motivating, empowering and developing people. Demonstrated skills in negotiation and consensus decision making. Demonstrated effectiveness in external partner relationship management. Understanding of medical/scientific terminology. Knowledge of PV regulations for global pre- and post-market products. Good analytical/judgment capabilities to understand/analyze/synthesize and communicate successfully as well as key decision making capability. Project Management abilities. Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives. Able to manage both time and priority constraints and to manage multiple priorities simultaneously. Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills. $170,000 - $200,000 USD 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. 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.
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Brisbane, CA Vera Therapeutics (Nasdaq: VERA), is a late clinical-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 fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and 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. Responsibilities
Ensure standards for collection and processing of ICSR, including alignment with GDPR requirements. Oversee development of global SOPs and policies to ensure compliance with regional PV regulatory requirements and to drive improvements in Vera global PV processes. Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, key performance metrics, and monitoring of performance and compliance, and training at a global level. Liaise with Vendor PV Systems team to ensure case processing SOPs and tools contain guidance to allow for timely and accurate submissions to global health authorities, partners, etc. Lead PV relationships with PV vendor(s) and ensure compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs). Oversee Post Marketed PV operations. Direct relationship with and output of vendor(s) in accordance with SOPs. Liaises VP of DSPV, financial / project management for budget planning. Approve invoices and confirm accuracy of spend and bills. Lead case processing teams to assess / predict case volumes to ensure staffing planning at vendor. Direct planning for ad-hoc case processing related projects e.g. Legal cases. Lead and facilitate regular joint operating committee meetings to review / address issues if needed for
Adherence to KPIs and Vera Standards Forecast demand Issue escalations Continuous improvement initiatives Change management
Manage / review delivery against MSA terms. Monitor global KPIs. Ensure quality of deliverables across teams. Represent voice of vendor to PV function. Provide guidance to delivery teams. Maintain operating procedures (describing operating rules with vendor). Lead change management and ongoing training. Establish and manage vendor oversight procedures. Partner with DSPV Compliance and QA teams to establish and manage vendor quality agreement procedures. Drive preparedness for regulatory authority inspection and internal audits for PV operational activities for Vera; participate in audits/inspections as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/inspection preparedness and participation. Qualifications
A minimum of a bachelor’s degree in a health/biomedical or related field, OR Registered Nurse, Licensed Practical Nurse, or Pharmacist with current certification/licensure (e.g., LPN, RN, RPh, PharmD) required. A minimum of 5 years of pharmaceutical or health care related industry experience required. Minimum 5 years PV experience with 3 years experience working with CROs, vendors, and relationship management preferred. Must have significant PV experience including experience working with CROs, vendors, and relationship management. Must have experience in Global PV inspections which include serving as an SME with direct contact with inspectors. Must have experience in preparing written responses from inspection findings, completing CAPA and implementing efficacy checks. Good cross cultural and cross functional understanding and experience, and ability to liaise with relevant teams/departments such as medical information, regulatory, affiliate relations. Experience in people management and well developed skills in teambuilding, motivating, empowering and developing people. Demonstrated skills in negotiation and consensus decision making. Demonstrated effectiveness in external partner relationship management. Understanding of medical/scientific terminology. Knowledge of PV regulations for global pre- and post-market products. Good analytical/judgment capabilities to understand/analyze/synthesize and communicate successfully as well as key decision making capability. Project Management abilities. Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives. Able to manage both time and priority constraints and to manage multiple priorities simultaneously. Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills. $170,000 - $200,000 USD 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. 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.
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