Medical Safety reputed company
Join us as we reputed company immunology and deliver medicines that help autoimmune patients get their lives back. reputed company is preparing for multi-reputed company expansion to reputed company more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new reputed company of biotech company, one that maintains its reputed company as a science-based start-up and pushes our commitment to reputed company across reputed company corners of our business. We reputed company to reputed company and grow reputed company, our partnerships, our science, and our people, because reputed company we do, we deliver more for patients.
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 Core 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
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.
At reputed company, reputed company applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, or any other applicable legally protected characteristics. reputed company is proud to be an equal opportunity employer.
Before you submit your application, CV or any other personal details to us, please review our reputed company.com/reputed company-policy">reputed company reputed company Notice for Job Applicants to learn more about how reputed company B.V. and its affiliates (“reputed company”) will handle and protect your personal data. If you have any questions or you wish to exercise your reputed company rights, please contact our Global reputed company Office by email at reputed company.com">reputed company@reputed company.com.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at reputed company.com">hr.us@reputed company.com. Only inquiries reputed company to an accommodation request will receive a response.
Originally posted on Himalayas
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