Pharmacovigilance Safety Writer

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.

The Pharmacovigilance Safety Writer is responsible for the preparation, quality check and distribution of aggregate safety reports (ASRs) and pharmacovigilance risk management plans (RMPs) for submission to regulatory agencies worldwide. The Pharmacovigilance Safety Writer is also responsible for observation of submission compliance worldwide and metrics/compliance preparation.

Essential Duties and Responsibilities:

• Write standalone post-marketing aggregate safety reports, such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), and associated reports, for regulatory submission.
• Serve as primary author for RMPs, utilizing various regional/local/company templates and ensuring compliance to regional/local regulatory requirements.
• Perform quality control reviews of ASRs and RMPs.
• Facilitate cross-functional document review and approval by other contributors.
• Ensure data issues are addressed and resolved prior to document sign-off.
• Ensure all assigned ASRs and RMPs are processed and submitted according to regulatory requirements and internal timelines.
• Distribute ASRs and RMPs for regulatory submission to internal contacts and business partners per the established schedules and within regulatory requirements.
• Regularly observe compliance, maintain compliance data, and prepare metrics.
• Respond to queries/requests/assessment reports from regulatory authorities regarding ASRs and RMPs.
• Lead cross-functional project teams tasked with activities related to the implementation, tracking, and effectiveness evaluation of RMP commitments.
• Perform safety surveillance activities for potential safety signals and provide guidance on the regulatory status.
• Participate on benefit -risk analysis, including safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans.
• Support the management in the establishment and maintenance of the ASRs and RMPs schedules.
• Support the management in audits and inspections.
• Demonstrate solid understanding of the role of internal policies, conventions, and procedures in completing report assignments.
• Support the creation, improvement and maintenance of standardized departmental procedures and processes.
• Lead and participate in assigned project teams and committees

Qualifications:

• Excellent scientific/clinical writing and editorial skills
• Excellent verbal and written communication skills in mother tongue and English (if not mother tongue)
• Familiarity with medical terminology and scientific writing
• Highly proficient computer skills and familiar with electronic publishing
• Solid understanding of pharmacovigilance regulation requirements for ASRs preparation, RMPs, and drug approval processes
• Ability to perform detailed scientific analysis/evaluation of specialized information to support decision making
• Editing proficiency including experience with document formatting (spelling, punctuation, capitalization, paragraph indentation, organization, style and conventions) for submission readiness
• Demonstrate the ability to respond to and resolve inquiries and problems relating to assigned ASRs and RMPs
• Ability to independently manage long- and short-term project timelines and deliverables.
• Experience in responding to queries/requests from regulatory authorities
• Operates effectively in a global team environment

Education and/or Experience:

• Medical degree is preferred, but also a bachelor’s degree in a medical/scientific field or 2(+) years pharmaceutical industry experience.
• Prior experience authoring ASRs and RMPs is required.
• Prior experience as a drug safety physician is desired.
• Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus
• Pharmacovigilance experience is required

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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