PV Benefit-Risk Safety Writer

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Summary:

We are currently looking for a PV Benefit-Risk Safety Writer to play a pivotal role in ensuring the safety and compliance of our pharmaceutical products worldwide. As the primary author of aggregate safety reports and risk management plans, you will have a direct impact on regulatory submissions and the success of our company. This is an exceptional opportunity to contribute to a world-class organization and make a difference in patient safety.

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.
• As the main writer, you will be responsible for creating PV-RMPs using different templates provided by the company, while ensuring compliance with regional and local regulatory standards.
• Perform quality control reviews of ASRs and PV-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/PV-RMPs are processed and submitted according to regulatory requirements and internal timelines.
• Distribute ASRs/PV-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 PV-RMPs.
• Lead cross-functional project teams tasked with activities related to the implementation, tracking, and effectiveness evaluation of PV-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 ASR/PV-RMP 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 on assigned project teams and committees.

Requirements:

• Equivalent experience in the pharmaceutical industry or a Bachelor's degree in a medical/scientific field; advanced degree and prior pharmaceutical industry experience is desired.
• Prior experience authoring ASRs/PV-RMPs is required
• Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus
• Pharmacovigilance experience is a required
• Excellent scientific/clinical writing and editorial skills
• Strong proficiency in both the primary language and English, with excellent verbal and written communication abilities.
• 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, PV-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 PV-RMPs
• Ability to independently manage long- and short-term project timelines and deliverables.
• Experience in responding to queries/requests from regulatory authorities
• Thrives in a collaborative team setting with diverse perspectives

What we offer:

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance (Family Responsible Certificate efr)
• Flexible benefits (childcare vouchers, employee discounts, etc.)
• Commitment to growing and developing an inclusive and diverse workforce

Equal Employment Opportunity:

We are an equal opportunity employer and is therefore firmly committed towards making employment opportunities available to all qualified applicants without regard to gender, race, age, disability, colour, nationality, ethnic or national origin, marital status, sexual orientation, responsibility for dependents, religion or trade union membership.

Reasonable Accommodations

Baxter 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.

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