Job Code:
Location: East Coast

• Handle adverse events according to national and international regulatory requirements and as per the departmental and corporate SOPs
• Ensure adequacy of recording, summarizing, and handling of adverse events for both investigational and marketed products including decisions on seriousness and expectedness and causality
• Ensure accuracy and timeliness of expedited reports from postmarketing safety surveillance and from clinical trials
• Review literature articles (both published and yet to be published) following established procedures
• Ensure accurate MedDRA coding of adverse events from all sources
• Author Similar Event Analysis reports following established procedures
• Review safety sections of clinical trial protocols, investigator brochures, and informed consents for selected drug development programs
• Responsible for Pharmacovigilance signaling activities
• Participation in Pharmacovigilance group meetings
• Attend the clinical team meetings as a Pharmacovigilance representative for responsible products
• Serve as a resource for the Medical Information and Quality Assurance Teams
• Assist and support the activities of the teams, Pharmacovigilance and of Global Pharmacovigilance
• Provide expert advice on medical matters in general, and specifically on pre and post-marketing safety-related issues
• Participate and collaborate in the creation and review of Pharmacovigilance Standard Operating Procedures and other documents that support regulatory compliance
• Communicate and collaborate effectively in safety matters with Regulatory Affairs, Clinical Teams, Biostatistics, Data Management, Marketing, and the Legal Department
• Keep management informed of special concerns and developing safety problems with investigational or marketed products
• Collaborate with consultants concerning drug safety issues and pharmacoepidemiology studies
• Provide strategic input to and in certain instances lead safety analyses including, but not limited to aggregates safety reports, labeling documents, clinical trial protocols, investigator brochures, and Integrated Summaries of Safety
• Work with Clinical Teams and Project Management and interface with CRO Safety
• Perform such other duties as requested by management
QUALIFICATIONS Required
• M.D. degree or equivalent
• MedDRA training (may be provided after starting)
• GCP training (may be provided after starting)

Desired
• Graduate training/experience resulting in board eligibility/certification
• Prior experience in pharmaceutical medical research with specific experience in product safety/pharmacovigilance/benefit-risk optimization
• Postgraduate training in clinical epidemiology and biostatistics
• Specialization and experience in oncology

Experience:
Required
• Practical clinical experience/expertise

Desired
• Individual Case Safety Report handling, as well as periodic report, PSUR and variation preparation
• Expertise in clinical research and safety activities in a pharmaceutical/biotech company
• Practical experience working with MedDRA
• Experience/expertise in pharmacoepidemiology research
• Management experience

Skills/Knowledge
Required
• Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally
• Ability to manage/supervise activities in a fast paced and changing environment to ensure objectives are met in a timely manner and achieved within budget allocations
• Ability to understand the safety database

Other:
• Nature of the department and the information that flows through the group requires that the individual be able to work well and communicate effectively with people both inside and outside of the department in order to meet deadlines. Person needs to be able to adapt to the changing dynamics in workflow and react accordingly. Due to the sensitive nature of the data received, person must have integrity when handling the confidential data.