PV Benefit-Risk Safety Specialist

hace 3 semanas

Madrid, Madrid, España Baxter A tiempo completo
Transforming Patient Safety with Baxter

Baxter is revolutionizing kidney care and other vital organ support by separating our ~$5B Kidney Care segment into a standalone company, Vantive. As a PV Benefit-Risk Safety Writer, you will play a pivotal role in ensuring the safety and compliance of our pharmaceutical products worldwide.

Key Responsibilities:
  • Author standalone post-marketing aggregate safety reports, such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), and associated reports, for regulatory submission.
  • Create PV-RMPs using different templates provided by the company, 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.
  • Process and submit ASRs/PV-RMPs 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.
  • Support the management in the establishment and maintenance of the ASR/PV-RMP schedules.
  • Support the management in audits and inspections.
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.
  • 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.

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