[Hiring] Senior Pharmacovigilance Physician @MMS

Role Description

Senior Pharmacovigilance Physician distinction is based upon education, previous experience, and level of independence and expertise. Senior Physician independently manages more complex medical-review assignments, provides more comprehensive medical judgment on safety issues, leads client discussions on medical topics, and serves as a medical subject-matter expert for other reviewers.

• Expertise in end-to-end signal management and safety surveillance activities
• Experience with signal management applications
• Represent the Company in signal management and safety surveillance interactions internally and externally
• Perform and provide oversight to signal detection activities to ensure compliant processes
• Maintains an extensive understanding of regulations and guidance as they pertain to medical review; mentors others and updates MMS and clients on related regulatory updates
• Proficient with various tools, such as MeDRA, WHODRUG, Bradford Hill Criteria, RSI, etc., used during medical review
• Proficient with medical reviewer and client processes, including QC process
• Proficient with medical review of safety deliverables for inclusion of relevant medical information, suggesting deletion of irrelevant information, and to ensure it makes sense from a medical perspective
• Proficient in coding of clinical database data using MedDRA (Adverse events, medical history) and WHO Drug dictionary (concomitant medications)
• Proficient in safety analysis process used to identify potential new safety signal, aggregate report authoring and experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical information (e.g., DSURs, PADER, PBRER)
• Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection
• Reviews individual case safety reports (ICSRs) from clinical trials, literature, and other sources
• Proficient in understanding impact of updates in related deliverables
• Proficient with managing client meetings, feedback and SRMs
• Proficient with identifying and mitigating project risk, including assessing client gaps
• Provides mentorship to others on medical review, safety signaling and pharmacovigilance
• Experience in medical monitoring preferred

Qualifications

• MD or DO required, board certification preferred
• Minimum of 5 years’ experience in pharmacovigilance, safety signal detection and aggregate report review/authoring or as a Safety Specialist, Medical Reviewer or similar field required
• Expert knowledge of scientific principles and concepts
• Reputation as emerging leader in field with sustained performance and accomplishment
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred
• Good communication skills and willingness to work with others to clearly understand needs and solve problems
• Excellent problem-solving skills
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process