Medical Safety Physician

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Provides medical, clinical, and scientific advisory expertise in clinical research studies and post-marketing programs (RWI).

• Engages in signal detection and aggregated reporting.

• Delivers medical, scientific, and therapeutic expertise pertaining to pharmacovigilance services.

• Involved in all facets of Medical Safety activities according to the scope of work.

• Conducts medical reviews and clarifications of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summaries.

• Drafts, edits, and medically reviews Analyses of Similar Events (AOSE) for expedited cases as necessary, adhering to regulatory standards.

• Acts as an internal consultant for pharmacovigilance case processing teams on supported projects.

• Conducts aggregate reviews of safety information, including clinical data, to ensure oversight of a product’s safety profile.

• Represents safety and clinical data review outcomes during client meetings.

• Provides medical review and edits of safety reports or other benefit-risk assessments.

⛳️ Requirements

• Experience with Argus.

• Self-starter.

• Background in pharmacovigilance and infectious disease vaccines.

• A valid medical license (active or inactive), or an equivalent qualification, from the country or region where the individual resides and works.

• 5 to 7 years of relevant prior experience.

• Extensive knowledge in one or more related fields typically acquired through advanced education combined with practical experience.

• Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.

🏝️ Benefits

• Medical Safety Physician Contract Job Description