3 дня назад
Signal Management Expert
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Signal Management Expert (Pharmacovigilance): Operationalizing and improving signal management processes and systems for product safety surveillance with an accent on regulatory compliance, signal detection, and cross-functional collaboration. Focus on evaluating safety data sources, implementing digital systems, measuring interconnected processes, and supporting global safety stakeholders.
Location: Morristown, New Jersey, United States; onsite
Company
is an R&D-driven, AI-powered biopharma company developing medicines and vaccines focused on immunoscience and patient health.
What you will do
- Operationalize and continuously improve compliant signal management processes across pharmacovigilance and related functions.
- Manage routine signal detection processes, tracking systems, metrics, oversight, and signal assessments.
- Monitor regulations, scientific literature, and professional societies for process and system improvements.
- Partner with digital teams to administer and implement systems supporting signal detection and management.
- Evaluate data sources, methods, and tools used in safety surveillance.
- Train and support Global Safety Officers, Pharmacovigilance Scientists, Therapeutic Area Heads, and Country Safety Heads while overseeing outsourced pharmacovigilance activities.
Requirements
- At least 2 years of experience in a pharmaceutical, biotech, or other regulated environment.
- Experience evaluating, interpreting, and communicating scientific data.
- Experience implementing process improvements, including corrective and preventive actions.
- Working knowledge of pharmacovigilance and drug safety practices, including US and EU regulatory requirements.
- Bachelor’s degree in healthcare, life sciences, or a STEM discipline; an advanced degree such as PharmD, MSc, or PhD is preferred.
- Business-proficient English, strong process analysis skills, database knowledge, and proficiency with Microsoft applications.
Culture & Benefits
- Supportive, future-focused environment with opportunities for promotion or lateral career moves.
- Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Rewards package and opportunities to work with AI, data, and digital platforms in drug discovery.
- Patient-focused drug development informed by patient insights and real-world needs.
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