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`Medical Director Medical Safety Evdaluation

Company: Robsco Search
Location: Jersey City
Posted on: May 18, 2020

Job Description:

Medical Director, Medical Safety Evaluation (MSE) The Medical Director Medical Safety Evaluation (MSE) is responsible for the management of the Medical Safety Evaluation Office of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Incumbent implements corporate policies to ensure the safety of the product in global development portfolio. The Medical Director is accountable for providing medical input to the assessment of the safety profile for each drug and for appropriate and timely regulatory reporting of safety issues. Responsibilities: Leads overall medical safety evaluation for global investigational products and clinical development program. Participates in FDA or other health authority safety interactions/responses with support from his/her manager. Has full accountability for all aspects of the global drug safety function, including development/delivery of a quality Pharmacovigilance system for assigned products/activities. Is theprimary safety representative between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, external experts, and CROs) on product safety related issues. Leads safety signal detection activities and global cross functional safety teams, with appropriate communication/escalation (eg label/IB updates).Oversees/conducts signal tracking for products according to regulatory requirements and corporate business strategy. Completes/reviews medical assessments of safety data [Periodic Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents; as appropriate) and ensures the benefit/risk information is accurate. Oversees development and preparation of Risk Management Actions Plans for regulatory filings. Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing. Works with cross-functional commercial teams to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities. Oversees data collection, processing, assessment, and preparation of case reports, annual reports, and periodic reports to ensure the timely submission to international regulatory agencies. Provides overview of the safety aspects of the planning, execution, data collection and interpretation of clinical research.Performs medical review/approval of medically coded safety data, including adverse events, medical history and concomitant medications. Accountable for the performance and results of the Drug Safety department and provides medical advice, training, and support. Implements department plans and priorities to address business and operational challenges. Develops and implements strategies for Pharmacovigilance business plans in accordance with long-term company strategic plans. This includes active involvement and coordination with local and international Pharmacovigilance directors and physicians. Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements.Improves organizational efficiency through outsourcing and other alliances. Provides input to senior management, as requested, regarding safety aspects of brand strategy, key messages, data review, and future data needs. Performs other departmental duties as assigned. Qualifications Medical Degree (MD or DO); current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience desired Minimum of 3+ years pharmacovigilance/safety physician experience US clinical practice experience preferred Exposure or experience writing pharmaceutical regulatory or clinical research documents, including periodic safety reports and risk management plans Post-graduate training in clinical epidemiology and biostatistics is also desirable Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Familiarity with US and International Safety reporting regulations and guidelines (in particular, ICH clinical safety guidelines) Exposure or experience in Phase I-III trials, especially with key activities (e.g. SMMP, CRO interaction, Safety-Clinical Database reconciliation, expedited reporting, AOSE, IND update, AR, ISS) Exposure or experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) Contributor for PSUR, RMP, and DSUR documents Exposure or experience with safety databases Willingness to travel domestically and internationally typically 20%

Keywords: Robsco Search, Jersey City , `Medical Director Medical Safety Evdaluation, Healthcare , Jersey City, New Jersey

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