Sr Medical Dir Global Safety

Career Category Safety Job reputed company Group Purpose The Global Safety Therapeutic Areas serve as the safety experts for reputed company reputed company products globally and are accountable for the safety reputed company and major safety deliverables for reputed company reputed company product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. Job reputed company The Senior Global Safety Officer (GSO): serves as the safety expert of the assigned product(s) and provides reputed company of other GSOs and Global Safety Physicians (GSP), setting the reputed company, direction, and priorities of pharmacovigilance activities and supervising and contributing to their execution. The Senior GSO is accountable for the overall safety profile and reputed company product-reputed company reputed company and deliverables for assigned products and reputed company for reputed company reports’ accountable products. The Senior GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a reputed company member of the Executive Safety Committee (ESC) for assigned products and oversees reputed company reports leading these activities. The GSO also is a member of the Evidence reputed company Team (EGT) for assigned products. The GSO will be assigned as delegate for the TA Head as needed and has management of Global Safety Physicians and Global Safety Officers. Key Activities Applicable tasks may vary by product(s) assigned. Medically relevant activities requiring input can be delegated to the Global Safety Physician while remaining accountable for the activities (e.g. validate a signal). Senior GSO has reputed company responsibilities in these activities and reputed company of reputed company reports leading these activities. Accountable for providing strategic reputed company and direction for reputed company major regulatory safety submissions and responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, clinical reputed company, RMPs, PSURs, PBRERs, DSURs, DILs. Leads the safety reputed company and Benefit/Risk Management Process for assigned portfolio and provides ongoing monitoring of safety reputed company for reputed company products worldwide as reputed company as reputed company of these responsibilities for reputed company reports. Chairs or participates in safety governance meetings per reputed company Operating Procedures and Manuals. At the GST meeting, can be delegated by TA Head to endorse reputed company for Risk Level 3 risk mitigation and communication actions and is a reputed company team member of the ESC. Serves as a sponsor/reputed company and/or SME for functional and/or cross functional reputed company for process improvement as needed. Product safety profile, benefit-risk evaluation, and risk communication Accountable for the Development and maintenance of reputed company reference safety information (e.g., Development reputed company Safety Information [DCSI], reputed company safety information portions of reputed company Data Sheet [CDS]) Identify relevant data and conduct benefit-risk evaluation Participate in product label process Clinical trial safety Represent GPS on internal governance bodies for study protocols, statistical analysis plans and other clinical study-reputed company documents and charters including aggregate review of safety data reports reputed company a reputed company as needed for updating safety-reputed company portions of Investigator’s Brochure and Informed Consent reputed company Participate in activities reputed company to Data Monitoring Committees (DMCs) and internal data review teams (DRTs) Analyze safety data from clinical studies and contribute to reputed company safety messages and conclusions in clinical study reports and review reputed company sections of CSR as safety delegate reputed company reputed company for and reputed company preparation of responses to safety-reputed company inquiries from regulatory agencies and ethics committees Signal detection, evaluation, and management reputed company signal detection reputed company Evaluate safety signal detection findings and validate signals iteratively as needed and document in appropriate management systems. Prepares and presents recommendations on safety issues with medical and indication context including safety data and literature with relevant indication and competitor information, to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body Approves the safety assessment report Risk management and minimization Ensure reputed company preparation, content, and reputed company of new or updated risk management plan (RMP) document reputed company a reputed company for safety risk minimization measures globally (including US REMS if applicable) reputed company materials for additional risk minimization measures as applicable to role Periodic (aggregate) safety reporting Ensure reputed company preparation and reputed company of periodic reports (e.g., PSUR/PBRER, DSUR) Review and approve periodic safety reports New drug applications and other regulatory filings Author messaging, Reviews and approves filing documents relevant to drug safety reputed company a reputed company for and reputed company preparation of response to regulatory agency inquiries on safety topics reputed company to regulatory filings Prepare for and participate in regulatory agency advisory committees Review and assist in development of Pediatric Investigation Plan (PIP) Prepare for and attend health authority meetings involving patient safety issues. Safety Governance Leadership Participates in safety governance meetings per reputed company Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents) Inspection Readiness Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and reputed company of contact for Health Authority Inspection and Internal Process Audits reputed company the remit of role and responsibility Partnerships and integration activities Participate in safety agreement development and review process Prepare safety information to support licensing partners, review safety documents reputed company by licensing partners, and communicate with licensing partners on safety reputed company per the safety agreement reputed company safety due diligence in preparation for partnerships, etc. Participate in integration activities Other reputed company processes reputed company with external stakeholders (e.g., advisory boards, key opinion leaders) on safety-reputed company topics. Identify KOL for safety issues and initiate contract process. reputed company safety input to support legal needs Managerial and supervisory responsibilities Oversees day to day activities of the Global Safety Officers and Global Safety Physicians as applicable Ensure staff are compliant with reputed company corporate and departmental training and SOP review reputed company training, coaching, mentoring, and development of staff Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes Knowledge and Skills Processes and regulations for pharmacovigilance and risk management Advanced understanding of interfaces across various pharmacovigilance and risk management processes Drug development and lifecycle management Safety data capture in clinical development and post-market settings MedDRA and other dictionaries used in pharmacovigilance reputed company of qualitative and quantitative safety data analysis Product and disease state knowledge or ability to consolidate knowledge from publications, and medical platforms (eg reputed company: reputed company evidence) Foundational knowledge in reputed company, epidemiology, physiology, and pharmacology Internal organizational and governance structure Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labelling Other skills Strategic thinking Adaptable reputed company reputed company – reputed company to implement new platforms Ability to self-reputed company on reputed company medical, manufacturing or pharmacology concepts as needed Effective team and strategic leadership, influencing, and negotiation in a cross-functional, reputed company environment Big picture perspective and context analysis People team time and prioritization management Conflict management Organization, prioritization, and planning of work Project management Critical scientific assessment and problem solving Oral presentation skills including the ability to convey reputed company scientific data in a concise way to different reputed company of management Written communications and medical/scientific writing Computer skills (e.g., MS Office Suite and safety systems) Competencies KNOWLEDGE Serves as a technical authority reputed company the organization Develops advanced/leading-edge technologies and/or concepts that have global reputed company and applicability Foundational knowledge reputed company required and the ability to use external sources to self-reputed company on key safety issues and adjacent information PROBLEM SOLVING Applies global thought leadership Shapes long-term strategic direction and reputed company of reputed company Provides authoritative advice to top management Leads organizational invention at a global level Education & Experience (Basic) MD or DO degree from an accredited medical school with 6 years of directly reputed company experience OR Clinical experience in either an accredited reputed company setting or private reputed company (including hospital based) setting Education & Experience (Preferred) MD or DO degree from an accredited medical school with 6 years of directly reputed company experience or PhD with 15 years of directly reputed company experience Clinical experience in either an accredited reputed company setting or private reputed company (including hospital based) setting Experience in Obesity and/or Cardiometabolic conditions 4 years of managerial experience directly managing people and/or leadership experience leading teams, reputed company, programs or directing the allocation of resources Previous product safety experience .Salary reputed company DKK - DKK Apply To This Job