Senior Physician Safety Specialist
il y a 3 jours
Vantive: Transforming Kidney Care
Baxter is embarking on a transformative journey to establish Vantive as a standalone company, building on our legacy in acute therapies and home and in-center dialysis. This move will enable Vantive to provide best-in-class care to those we serve, while also offering meaningful work to those who join us.
At Vantive, we are a community of individuals driven to improve patients' lives worldwide. We are revolutionizing kidney care and other vital organ support, and we invite you to be part of this journey.
Role Overview
The Senior Physician Safety Writer is responsible for preparing, quality-checking, and distributing aggregate safety reports (ASRs) and pharmacovigilance risk management plans (PV-RMPs) for submission to regulatory agencies worldwide. You will also be responsible for monitoring submission compliance globally and preparing metrics and compliance reports.
Key Responsibilities
- Author standalone post-marketing aggregate safety reports, including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), and Periodic Adverse Drug Experience Reports (PADERs), 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.
- To ensure that appropriate medical interpretation and consistency are applied to periodic documents, product labels, and adverse event case assessment.
- To perform aggregate safety data review, safety surveillance activities to review for potential safety signals and provide guidance on the regulatory status for expedited reporting and/or signal detection.
- To share medical/clinical expertise with counterparts in other functional areas such as quality assurance, regulatory affairs, marketing, manufacturing, and legal globally.
- To provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities.
- To review and provide assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents.
- To 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.
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