7 дней назад
PV Specialist, Case Processing (Pharmacovigilance)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
PV Specialist, Case Processing (Pharmacovigilance): Processing clinical trial and post-marketing adverse event cases with an accent on MedDRA coding, case assessment, follow-up activities, and safety narratives. Focus on reviewing case quality, resolving discrepancies, supporting client notifications, and maintaining knowledge of global medicine safety regulations.
Location: Makati City, Philippines. supports remote working and encourages hybrid work for new hires within a reasonable commute of an office, as agreed with the manager.
Company
provides consulting and operational services across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology.
What you will do
- Process daily clinical trial and post-marketing adverse event cases.
- Code cases using MedDRA and determine seriousness and expectedness at event and case level.
- Identify follow-up information requirements, create and review case narratives, and provide client notifications.
- Perform peer reviews to ensure case quality, consistency, and accuracy.
- Support the development and delivery of training materials.
- Escalate ICSR concerns and discrepancies to the Principal PV Specialist or Case Processing Manager.
Requirements
- Bachelor's degree in life sciences.
- Two years of related work experience.
- Basic knowledge of pharmacovigilance and global medicine safety regulations.
- Strong verbal, written, and interpersonal communication skills.
- High accuracy, attention to detail, organization, prioritization, and problem-solving abilities.
- Ability to work independently and collaboratively in a multidisciplinary team.
Nice to have
- Advanced degree, RN, RPh, PharmD, or equivalent qualification.
Culture & Benefits
- Remote working is supported, with hybrid collaboration encouraged for employees located near an office.
- Work in an environment focused on diversity, equity, inclusion, and individual authenticity.
- Collaborative and entrepreneurial workplace culture.
- Equal opportunity employer committed to a safe and supportive work environment.
Hiring process
- Applications are reviewed personally by a member of the recruitment team.
- AI screening tools are not used.
- Applicants receive an outcome after the application review.
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