Looking for someone based in East Coast to support EST time zone. The Consultant Medical Safety Physician, Drug Safety, will be responsible, as required, for medical review of individual case safety reports, performing aggregate safety data review and safety surveillance activities for potential safety signals, and review and assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents.
• Provide medical review of individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and Company causality assessment for an assigned therapeutic area
• Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment
• Participate in the Pharmacovigilance Committee activities
• Maintain knowledge of global regulatory authority regulations (especially FDA and EMEA)
• Provide pharmacovigilance support for internal and external customers
• Communicate and interact effectively within and across therapeutic teams, and within functional team management as appropriate
• Perform aggregate safety data review, safety surveillance activities to review for potential safety signals, and provide guidance on the regulatory status for expedited reporting and/or signal detection/trends
• Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
• Review and provide assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents including Investigators' Brochures, PSURs and ad hoc regulatory reports as assigned. This includes input to PSURs and PADERs with focus on providing overview for the medical analysis and safety sections.
• Work with labeling team to accurately portray the safety profile of assigned drugs or biologics
• Contribute to the training, leadership and continuing education for all departmental staff
• M.D. degree or international equivalent
• At least 5+ years of experience post-residency, with at least 3 years of experience in a pharmaceutical/biotechnology company
• Knowledge and understanding of national and international regulatory guidelines are a plus
• Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice
• Exposure to working relationship with the FDA and other regulatory authorities is preferred
• Knowledge of industry regulations and drug safety practices
• Strong knowledge of adverse event case report triage processing
• Experience with commercial databases and safety coding dictionaries (MedDRA, WHODRUG)
• Excellent oral and written communication skills
• Excellent teamwork and interpersonal skills are required
• Strong skills in presenting drug safety topics for regulatory authorities, or at conventions, meetings, etc.