PV Physician

M / S MIG DOOR VISAS IMMIGRATION; Hamilton; Remote; CAD 70,000 - 90,000; Full time

Job summary

An immigration consultancy is seeking a qualified individual to manage safety reports related to clinical trials. This includes reviewing literature and contributing to safety reports while ensuring compliance with regulations. Ideal for professionals with experience in safety assessments in the pharmaceutical domain.

Responsibilities

• Review and approve post-marketing ICSR and SAE reports.
• Assess literature for ICSRs/SAEs related to medicinal products.
• Participate in signal detection activities and reporting.

Job description

Call or WhatsApp to check your eligibility

Aman - 9863937736

Job location : Only overseas countries

Role & Responsibilities

• Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports from clinical trials, including coding, seriousness assessment, listedness/expectedness, and causality evaluation. Write comments, follow-up questions, and analyze similar events, ensuring all documentation is complete.
• Review literature screening search strategies.
• Assess articles for ICSRs/SAEs related to the medicinal product or safety findings.
• Review database outputs.
• Contribute to Periodic Safety Update Reports.
• Contribute to Development Safety Update Reports.
• Participate in signal detection activities, including meetings and report writing.
• Propose actions if a potential safety signal is identified.