2 дня назад
Senior Pharmacovigilance Safety Scientist, Benefit Risk
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Pharmacovigilance Safety Scientist, Benefit Risk (Pharmacovigilance): Authoring and quality-reviewing aggregate reports, Risk Management Plans, and Signal Management Reports with an accent on regulatory compliance, literature screening, and benefit-risk activities. Focus on validating safety data, coordinating PV Scientists, mentoring subject matter experts, and delivering high-quality submissions within agreed timelines.
Location: Serbia; remote working is supported, with hybrid work encouraged for new hires within a reasonably short commute of an office.
Company
provides consulting and operational expertise across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.
What you will do
- Author and quality-review aggregate reports, including PSURs/PBRERs, PADERs, annual reports, ACOs, and DSURs.
- Author and review Risk Management Plans and Signal Management Reports.
- Perform literature searches, validity checks, duplicate searches, and safety-data extraction and validation.
- Generate and quality-check line listings from safety databases and maintain relevant process trackers.
- Coordinate PV Scientists, provide subject matter expertise, and train and mentor colleagues.
- Support audits, inspections, client discussions, ad-hoc activities, and delivery of compliant outputs within agreed timelines.
Requirements
- Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Science, another health-related field, or equivalent qualification or experience.
- At least 4 years of pharmacovigilance experience, with a focus on Risk Management Plans.
- Experience presenting metrics and leading internal and client discussions about quality.
- Experience with literature screening, aggregate report authoring or review, RMP authoring or updates, signal detection methodologies, CCDS management, or regulatory safety variation processes.
- Ability to independently plan and execute aggregate report preparation and coordinate assigned deliverables.
Culture & Benefits
- Remote working is supported, with hybrid collaboration encouraged where practical.
- Inclusive and equal-opportunity workplace focused on diversity, equity, and inclusion.
- Environment that supports innovative, collaborative, and entrepreneurial work.
- Applications are personally reviewed by the recruitment team without AI screening tools.
- Applicants receive an outcome regarding their application.
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