About this role
MMS, an award-winning, data-focused clinical research organization (CRO), is hiring a Senior Pharmacovigilance Physician (Remote - US, multiple states, full time) for its Drug Safety team. MMS supports the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submission challenges.
The Senior Pharmacovigilance Physician independently manages complex medical-review assignments, provides comprehensive medical judgment on safety issues, leads client discussions on medical topics, and serves as a medical subject-matter expert for other reviewers. Responsibilities include end-to-end signal management and safety surveillance, signal detection oversight, medical review of safety deliverables, coding of clinical database data using MedDRA and WHO Drug dictionary, authoring and reviewing aggregate safety reports (DSURs, PADER, PBRER), reviewing individual case safety reports (ICSRs), managing client meetings and SRMs, identifying and mitigating project risk, and mentoring others on medical review and pharmacovigilance.
Requirements: MD or DO required (board certification preferred); minimum 5 years' experience in pharmacovigilance, safety signal detection, and aggregate report review/authoring, or as a Safety Specialist/Medical Reviewer; expert knowledge of scientific principles; proficiency with MS Office; familiarity with ISO 9001/27001, 21 CFR Part 11, FDA, and GCP requirements; and strong communication and problem-solving skills.