Senior Physician Safety Writer H/F
il y a 1 semaine
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.
Key Responsibilities
- Prepare, quality check, and distribute aggregate safety reports (ASRs) and pharmacovigilance risk management plans (PV-RMPs) for submission to regulatory agencies worldwide.
- Observe submission compliance worldwide and prepare metrics/compliance reports.
- 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 PV-RMPs, utilizing various regional/local/company templates and ensuring compliance to regional/local regulatory requirements.
- Perform quality control reviews of ASRs and PV-RMPs.
- Facilitate cross-functional document review and approval by other contributors.
- 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.
- 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 audits and inspections.
- Support the creation, improvement, and maintenance of standardized departmental procedures and processes.
- Perform benefit-risk safety analysis, including safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans.
- Ensure that appropriate medical interpretation and consistency are applied to periodic documents, product labels, and adverse event case assessment.
- Share medical/clinical expertise with counterparts in other functional areas such as quality assurance, regulatory affairs, marketing, manufacturing, and legal globally.
- Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities.
- Review and provide assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents.
- Work with global labeling team to accurately portray the safety profile or assigned drugs.
Requirements
- Medical degree with a minimum of 2 years pharmacovigilance industry experience.
- Prior experience authoring ASRs/PV-RMPs and providing medical knowledge for safety signal work-ups and benefit-risk assessments is desired.
- Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus.
- Excellent scientific/clinical writing and editorial skills.
- Outstanding verbal and written communication skills in English.
- 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.
- Ability to independently manage long- and short-term project timelines and deliverables.
- Operates effectively in a global team environment.
*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.
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