Vantive: Building on Legacy
Baxter is transforming its ~$5B Kidney Care segment into a standalone company. Vantive will leverage our 70-year legacy in acute therapies and home/in-center dialysis to deliver exceptional care. We believe Vantive will strengthen our leadership in kidney care, offering meaningful work to those who join us.
At Vantive, you'll be part of a community driven to improve patients' lives worldwide. Together, we're revolutionizing kidney care and vital organ support.
Summary:
We seek a PV Benefit-Risk Safety Writer to ensure the safety and compliance of our pharmaceutical products globally. As primary author of aggregate safety reports and risk management plans, you'll impact regulatory submissions and our company's success.
Responsibilities:
* Write standalone post-marketing aggregate safety reports (PBRERs, PSURs, PADERs) for regulatory submission.
* Create PV-RMPs using provided templates, ensuring compliance with regional and local regulations.
* Perform quality control reviews of ASRs and PV-RMPs.
* Facilitate cross-functional document review and approval.
* Address data issues prior to document sign-off.
* Ensure timely processing and submission of ASRs/PV-RMPs according to regulatory requirements.
* Distribute ASRs/PV-RMPs to internal contacts and business partners.
* Maintain compliance data and prepare metrics.
* Respond to regulatory queries/requests regarding ASRs and PV-RMPs.
* Lead cross-functional project teams for PV-RMP implementation and effectiveness evaluation.
* Schedule and track ASR/PV-RMP deadlines.
* Support audits and inspections.
* Demonstrate understanding of internal policies and procedures.
* Support creation and maintenance of standardized departmental procedures.
* Lead/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 desired.
* Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus.
* Pharmacovigilance experience is a plus.
* 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.
* Edit documents for submission readiness, including formatting (spelling, punctuation, capitalization, paragraph indentation, organization, style, and conventions).
* Able to resolve inquiries and problems relating to assigned ASRs and PV-RMPs.
* Ability to independently manage long- and short-term project timelines and deliverables.
* Experience 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.
* Emphasis on work-life balance.
* Flexible benefits (childcare vouchers, employee discounts, etc.).
* Commitment to growing and developing an inclusive and diverse workforce.