Manager Global Safety Operations

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your role at Vantive

This position is a member of Global Patient Safety -Global Safety Operations, Safety Systems and Data Management. This role encompasses support and management of Safety Operations supporting Vantive products globally, including the responsibility of individual Case processing, Literature, Quality Control, Clinical Case processing.

The manager will perform a quality review of work performed by the PV outsource vendor providing instruction and training as needed.

In addition, this role works closely with Local Patient Safety, to ensure regulatory compliance of US and Canada according to PV regulations and supports audits and regulatory inspections by FDA and Health Canada.

The manager ensures that Safety Operations are performing in compliance with global standards, policies and procedures related to pharmacovigilance.

What your'll be doing

Safety Operations

• Responsible and accountable for the management of daily operations, including adverse event case processing, global literature search and submission of ICSR to Health Authorities worldwide in compliance with regulations.

• Manage global vendor in charge of the adverse event case processing, including vendor oversight ensuring that any quality deviation and or miss of KPIs is properly addressed and a CAPA is initiated if needed.

• Act as the point of contact for global case processing vendor queries.

• Determine root causes of nonconformance and assist in developing effective problem solution strategies to ensure compliance with safety information reporting to HAs worldwide.

• Support preparation of responses to PV audits and inspections in relation to Local PV activities and related matters, including CAPA investigation and writing

Other ad-hoc support:

• Cover team member absences and provide support during periods of high workload in Safety Systems and Data Management to ensure seamless business continuity

• Support review and testing of upgrades and or changes implemented by the global vendor of ARGUS safety database.

What you'll bring

• Minimum of 3 years in direct people management, including coaching, mentoring, and providing feedback.

• Ability to collaborate effectively in a complex matrix organization.

• Broad understanding of the global regulatory environment.

• Excellent analytical and problem-solving skills.

• Mature personality with excellent leadership and interpersonal skills

• Excellent oral and written communication.

• Comfort and confidence presenting pharmacovigilance operational aspects, particularly to regulators.

• Leadership experience in managing direct and shared resources, some at a geographic distance.

• Cultural fit with Company's values.

• Bachelor of Science, or more advanced degree in relevant scientific discipline

• Minimum of 5 years of working experience in Safety Operations

• Knowledge and understanding of case processing regulations and guidelines worldwide

• Expert knowledge of Pharmacovigilance Safety Systems (ARGUS, and other safety database applications) and electronic data capture systems.

• Working experience on PV vendor management.

• Exposure to working relationships with the FDA and other regulatory agencies is preferred.

• Accountable for responding to PV audits/inspections in relation to Safety Operations related matters, working within Vantive Quality Management System (QMS), to open corrective actions/preventive actions (CAPAs) for Global Patient Safety audit/inspection finding and, where applicable, creating gap and risk mitigation plans to address any identified issues

• Leads Safety Global SME meetings.

• Manages Literature searches, search-string review and other Literature related activities including article ordering, translation request, copyright order.

• Attend and represent Safety Operations from SME perspective the bi-weekly management review meetings with global case processing vendor

• Performs quality check and case processing query resolution for global case processing vendors.

• Reviews Process errors submitted by global case processing vendor and act as investigation approver.

• Acts as a WF manager and address requests from affiliates for case nullification, workflow change etc.

• Responsible for review of SMP and protocols for clinical trials; providing instructions to global safety operations vendor and ensuring all case management activities are aligned.

• Works with the IT PV service provider to convert the GPS business needs into user requirements and deliverables that will assist in defining and validating the configuration of the end solution.

• Takes ownership and support with SOPs pertaining to Safety Operations.

• Provide expert advice and offer solutions to local PV affiliates worldwide related to Adverse Event case processing regulations for future improvements and learnings.

PV US and Canada (UCAN) region

• Act as a back-up for Local PV US and Canada, as required, to ensure business continuity and meeting the expectations from FDA and Health Canada regulators.

• Ensure compliance of PV operations according with applicable regulations and GPS procedures

• Jointly responsible for directing all UCAN (US FDA, Health Canada) PV inspections and audits, providing all aspects with on-site support, including, but not limited to preparing all subject matter experts (SMEs), scheduling all presentations with regulatory authorities and auditors, and ensuring support staff are equipped for "war room" activities.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 to $155,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), Vantive's 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Vantive's US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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