21 час 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/Risk Management): Authoring and quality reviewing aggregate safety reports, Risk Management Plans, and signal management reports for health authority submissions with an accent on regulatory compliance, literature assessment, and benefit-risk activities. Focus on validating safety data, coordinating PV scientists, mentoring subject matter experts, and delivering compliant client work within agreed timelines.
Location: Berlin, Germany. Remote working is supported; employees within a reasonably short commute of an office are encouraged to work on a hybrid basis.
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 validation.
- Extract and validate RSI, sales, prior report, RMP, and signal data, and generate and quality-check line listings.
- Coordinate PV Scientists, provide subject matter expertise, and train and mentor colleagues.
- Support audits, inspections, client issue resolution, ad-hoc activities, and on-time delivery of compliant client deliverables.
Requirements
- At least 5 years of experience in pharmacovigilance, with a focus on Risk Management Plans.
- Bachelor’s or master’s degree in pharmacy, nursing, life sciences, or another health-related field, or equivalent experience.
- Experience authoring or reviewing aggregate reports and/or authoring and updating RMPs.
- Experience with literature screening, signal detection methodologies, CCDSs, or regulatory safety variation processes.
- Experience presenting metrics and leading internal and client discussions about quality.
- Ability to work from Berlin, Germany, with remote or hybrid arrangements according to the role and manager agreement.
Culture & Benefits
- Inclusive workplace focused on diversity, equity, and inclusion.
- Environment encouraging innovation, collaboration, entrepreneurship, and authentic self-expression.
- Remote working support with opportunities for in-person collaboration.
- Applications are personally reviewed by the recruitment team without AI screening tools.
- Applicants receive an outcome after the application review.
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