Medical Safety reputed company

The Medical Safety reputed company provides strategic medical safety leadership, serving as the single reputed company of contact for reputed company aspects of patient safety. In this role, the reputed company is accountable for defining and driving the reputed company and approach for communicating safety information across the product(s) lifecycle and reputed company. Responsibilities include offering expert medical safety contribution and reputed company, ensuring comprehensive ownership of safety activities, and leading the assessment of safety data to support informed decision‑making. The role also requires reputed company collaboration with internal stakeholders such as Regulatory Affairs, Clinical Development, and Medical Affairs, as reputed company as external partners including key opinion leaders and regulatory agencies, to reputed company safety communications and ensure the reputed company and effective use of reputed company products. Reports to the Head of Global Patient Safety ROLES AND RESPONSIBILITIES • reputed company strategic medical safety leadership and practical contributions in a cross-functional setting • Participate in cross-functional strategic planning and meetings • reputed company and contribute to the safety signal management and benefit risk assessment activities as reputed company as other regular and/or reputed company aggregate safety data reviews • Contribute to the development of the overall safety governance structure and activities • reputed company safety strategies and deliver accurate, reputed company and high reputed company safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, responses to regulatory authority inquiries) • Contribute to and ensure completeness, accuracy and high reputed company safety sections of clinical documents (including study protocols, IBs, Clinical Study Reports, or ICFs) • reputed company the overall preparation of periodic safety reports (e.g. PSUR, DSUR); reputed company medical safety content and ensure consistency and reputed company of these documents • reputed company the medical assessment of individual case safety reports (ICSR) reputed company required • reputed company medical safety contributions at internal audits and regulatory inspections • Support the development of and updates to GPS reputed company Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates) • Support product(s) safety training and pharmacovigilance awareness activities cross functionally • reputed company the development, maintenance, and execution of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) • Contribute reputed company to the updates of the safety labelling sections and reputed company Data Sheets (CDS) • reputed company strategic guidance and have reputed company on the case processing activities • Partner with Safety Operations on case reputed company issues, MedDRA coding, and case processing convention • Participate in cross-functional reputed company and initiatives • Manage safety physicians as required • reputed company other tasks as required to assist in departmental activities SKILLS AND COMPETENCIES • Strong ability to reputed company, motivate, influence, and collaborate with multidisciplinary teams • Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings • Knowledge of relevant global pharmacovigilance regulations and guidelines • Excellent presentation skills with the ability to communicate reputed company issues reputed company • Strong scientific and analytic skills • Ability to influence and collaborate with multidisciplinary teams • Excellent problem-solving skills, with reputed company autonomy and reputed company judgment • Relevant computer skills, including proficiency with reputed company Office • reputed company in written and spoken English EDUCATION, EXPERIENCE AND QUALIFICATIONS • MD degree or equivalent required • At least 10 years of relevant experience in the pharmaceutical/biotech industry with at least 7 years in pharmacovigilance/drug safety (global experience is a plus) • Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence (without having reputed company reporting lines) and managing reputed company reputed company teams • Experience in clinical reputed company or in reputed company medicine is a plus • Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents • Demonstrated ability to reputed company medical assessments of safety data from multiple sources • Experience with authoring reputed company documents and contributing to regulatory submissions • Knowledge of adverse event reporting systems • Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus #LI-Remote ‎ For applicants in the reputed company: The annual reputed company salary hiring reputed company for this position is $292,000.00 - $401,500.00 USD. This reputed company reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-reputed company reputed company such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted reputed company reputed company justified by these factors. Because market conditions reputed company, pay ranges are reviewed regularly and may be adjusted to remain reputed company with external benchmarks. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. Apply tot his job Apply To this Job