Director - Pharmacovigilance Operations
To see similar active jobs please follow this link: Remote Management jobs
Title: Director, Pharmacovigilance Operations
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 Operations will report to the Executive Director, PV Operations & PV Science and will be responsible for providing Operations oversight for the global drug safety and pharmacovigilance function to ensure proactive and timely processing 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 Pharmacovigilance Operations activities through all stages of clinical development as well as post-marketing patient safety.
Responsibilities:
Ensure standards for collection and processing of ICSRs which include alignment with GDPR requirements.
Oversee development of global SOPs and policies to ensure compliance with regional PV regulatory requirements and to drive improvements in 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 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).
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
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 alongside the VP and ED of Vera DSPV; participate in audits/inspections as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/inspection preparedness and participation.
Qualifications:
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.
10+ years of pharmaceutical or health care related industry experience required.
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.
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 an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills.
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 Operations
To see similar active jobs please follow this link: Remote Management jobs
Title: Director, Pharmacovigilance Operations
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 Operations will report to the Executive Director, PV Operations & PV Science and will be responsible for providing Operations oversight for the global drug safety and pharmacovigilance function to ensure proactive and timely processing 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 Pharmacovigilance Operations activities through all stages of clinical development as well as post-marketing patient safety.
Responsibilities:
Ensure standards for collection and processing of ICSRs which include alignment with GDPR requirements.
Oversee development of global SOPs and policies to ensure compliance with regional PV regulatory requirements and to drive improvements in 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 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).
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
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 alongside the VP and ED of Vera DSPV; participate in audits/inspections as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/inspection preparedness and participation.
Qualifications:
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.
10+ years of pharmaceutical or health care related industry experience required.
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.
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 an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills.
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.