Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Summary:
The PV Benefit-Risk Safety Writer (PV-BRSW) is responsible for the preparation, quality check and distribution of aggregate safety reports (ASRs) and pharmacovigilance risk management plans (PV-RMPs) for submission to regulatory agencies worldwide. The PV-BRSW is also responsible for observation of submission compliance worldwide and metrics/compliance preparation.
Qualifications:
- Excellent scientific/clinical writing and editorial skills
- Excellent verbal and written communication skills in mother tongue and English (if not mother tongue)
- 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
- Operates effectively in a global team environment
Education and/or Experience:
- Bachelor’s degree in a medical/scientific field or 2(+) years pharmaceutical industry experience; 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
Reasonable Accommodation
Vantive 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. Form Link
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