• Overseeing the proper and timely collection and the timely reporting of Adverse Event information from all sources as required by regulation (clinical trials, literature, direct report, etc.)
• Preparation of all Safety reports (IND Safety Reports, IND / NDA updates, PSUR’s, Annual reports, etc.)
• Development and maintenance of all Pharmacovigilance related SOPs
• Development, Implementation and maintenance of the company safety database (s)
• Prepares and reviews Adverse Event Trending reports
• Prepares and reviews analysis / reports pertaining to Signal detection/surveillance activities at a medical qualitative level
• Provides medical input/expertise for Data Safety Review Board reviews/label evaluations
• Provides medical review/commentary and Risk Assessments related to ADE reports or associated with quality investigations on an individual case-level or aggregate review level.
• Liaises with company legal consultant regarding medical review/commentary for cases of special interest and matters of regulatory interpretation
• Participation in after hours medical coverage for clinical projects, if required
• Assist other Medical Directors with Project Specific Safety Monitoring
• Interaction with FDA and other regulatory authorities as necessary
• Develop and implement Pharmacovigilance programs and risk management plans
Operational, Medical and Scientific Support:
• Provide medical and scientific support to Quality Assurance and Regulatory Affairs with respect to customer complaints, Adverse Event Trending and regulatory agency inquiries.
• Provide medical and scientific support to Professional Services, and Marketing and Sales departments.
• Medical review of documents associated with product sales and marketing
• Review of protocols, case report forms, guidelines, clinical study reports and manuscripts as requested.
• Protocol and/or therapeutic area training for the project team as requested
• Participation in and/or presentation at Investigator Meetings as requested
• Interaction with CROs, consultants, investigators, outside physicians and other medical professionals
• Medical Safety support for Project Management, Data Management, Biometrics and Clinical Writing
• Strategic Planning / Business Development – Assessment of Pharmaceutical Product Development and providing medical/scientific opinion of new ventures
• Oversees completion and revision of work instructions/SOPs pertaining to post marketed processes
• Liaise w/ Shirley groups (QA/RA/Med Affairs (formerly PS)/Customer Svc) for resolution of any PV-related issues
• Participates in Quality Initiatives and any associated deviations as needed
• Tracks case processing metrics for monthly reports to Sr. Mgmt.
• Prepare SAE narratives, and collaborate with CROs for SAE reconciliation.
• Administrative tasks as required by Sr Management and/or Direct Supervisor to maintain smooth functioning of the Division and compliance with Regulation, Guidance and SOPs
• Training lectures, symposia and conferences in order to maintain current license and maintain and promote Company’s therapeutic area(s) expertise
• US Medical degree with three years experience preferred. Will consider PharmD or foreign medical degree with 5 years experience, or BSN, MSN with ten years experience.
• Pharmaceutical industry experience (Pharmaceutical or CRO) in Pharmacovigilance and Safety Surveillance, knowledge of drug development safety requirements and history of experience working with safety monitors essential
• Working knowledge of FDA reporting regulations as they pertain to human and veterinary drug products and medical devices for both marketed products and products under development
• Excellent oral and written English communication skills
• Significant computer / technology skills. PV Works safety database experience a plus
• Prior management experience as evidence by previous direct reports
• Drug development experience
• Experience as direct medical liaison with FDA
• Ability to prioritize and perform multiple tasks simultaneously
• Ability to make decisions independently and with appropriate input
• Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, Quality Assurance, Sales, Marketing and Professional Services
• Flexibility in adapting to multiple therapeutic areas interchangeably
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.