5 часов назад
Senior Pharmacovigilance Physician (Remote - US)
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 Physician (Drug Safety): Managing complex medical-review assignments, safety signal detection, surveillance activities, and aggregate safety reports with an accent on pharmacovigilance expertise, regulatory compliance, and clinical data interpretation. Focus on reviewing ICSRs, analyzing cumulative safety data, leading client discussions, and mentoring medical reviewers.
Location: Remote within multiple US states
Company
is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission services.
What you will do
- Independently manage complex medical-review assignments and provide expert medical judgment on safety issues.
- Lead end-to-end signal management, safety surveillance, and signal detection activities.
- Review individual case safety reports, medical review deliverables, and cumulative safety data.
- Author and review aggregate safety reports, including DSURs, PADERs, and PBRERs.
- Represent in internal and external signal management discussions and manage client meetings and feedback.
- Mentor medical reviewers on medical review, safety signaling, and pharmacovigilance practices.
Requirements
- MD or DO required; board certification preferred.
- At least 5 years of experience in pharmacovigilance, safety signal detection, aggregate report review or authoring, medical review, or a similar field.
- Strong knowledge of international safety reporting, pharmacovigilance requirements, and signal detection.
- Experience with clinical trials, pharmaceutical development, scientific and clinical data, and the drug development process.
- Familiarity with 21 CFR Part 11, FDA, GCP, ISO 9001, and ISO 27001 standards.
- Strong communication, problem-solving, collaboration, and MS Office skills.
Nice to have
- Medical monitoring experience.
- Board certification.
- Hands-on experience with clinical trial and pharmaceutical development.
Culture & Benefits
- Supportive, innovative, collaborative, and inclusive work environment.
- Great Place to Work certified organization.
- Remote work arrangement within the United States.
- Opportunity to work with pharmaceutical, biotech, and medical device clients across a global CRO.
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