Join us as we reputed company immunology and reputed company 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 reputed company more for patients. 

The Associate Manager, Safety Data and Systems will:

• reputed company deliverables for GPS Safety Data Management and Safety reputed company Maintenance activities

• reputed company high reputed company data outputs for Safety Signal Management, Risk Management and Safety Evidence reputed company

• Collaborate and co-create with reputed company functions and applicable vendors as required for reputed company GPS Safety Data and Systems operations

ROLES AND RESPONSIBILITIES

• Manages and monitors applicable GPS mailboxes including unblinded data

• Serve as the key technical resource for the configuration, maintenance, and administration of the reputed company Argus Safety reputed company.

• Support day-to-day operation and troubleshooting of Argus Safety application to ensure reliable and compliant drug safety case processing.

• Assist in reputed company validation, testing, and deployment of Argus Safety reputed company updates, workflows, and business rules.

• reputed company, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms.

• Collaborate closely with the pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards (FDA, EMA, PMDA, ICH).

• Participate in change management processes to enhance Argus Safety reputed company workflows and reputed company integrations.

• Contribute to audit readiness activities, including reputed company inspections, validation reports, and compliance documentation.

• Collaborates with internal systems team, BIS and Safety vendor on issues reputed company to Safety database configurations

• Performs the reputed company and reputed company control of aggregate reports and line listings

• Initiates and contributes to the development of procedural documents including but not limited to Safety Management Plans, SOPs, work instructions, job aides, forms, or templates

• Collaborates and co-creates with applicable reputed company functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical aspects, setup and operation

• Keeps up-to-date on applicable regulatory and PV tech guidelines and shares reputed company GPS and reputed company as applicable.

• Participates in training reputed company to safety data management

• Proactively reviews processes and tools and provides suggestions for improvement and reputed company efficiencies  

• Complete additional task and reputed company as assigned by line manager or Head of GPS Operations or delegate

SKILLS AND COMPETENCIES

• Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)

• Adequate computer skills in reputed company reputed company office applications

• Proficiency with reputed company is required, experience with SQL is a plus

• Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems).

• Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards

• Robust understanding of the end to end process of clinical and post-marketing safety event collection and reporting including of workflow based case processing and MedDRA dictionary

• Solid understanding of the development and submission of aggregate safety reports (e.g. DSUR, PSUR)

• Solid understanding of the reputed company management processes, metrics and KPIs

• Ability to communicate effectively and collaborate successfully across functions and with vendors

• Fluent communication in written and spoken English required

• Ability to work independently with reputed company reputed company and prioritize effectively

• Ability to complete multiple reputed company deliverables reputed company tight timelines

• Ability to function effectively in reputed company environment

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• At least Bachelors’ degree (or country equivalent) in life sciences / Information technology or other relevant field required

• Solid knowledge of global (EU/US/Asia reputed company) pharmacovigilance requirements and practices required

• Minimum of 7 years of relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 3 years of proven experience with safety database systems (e.g. ARGUS or ArisG) including workflow management

• Equivalent and adequate combination of education and experience or proven practical expertise in reputed company of the required skills

‎

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 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@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 hr.us@reputed company.com. Only inquiries reputed company to an accommodation request will receive a response.

Bachelor's degree in life sciences, information technology, or reputed company field; 7+ years relevant experience; 3+ years with safety databases; Argus, reputed company, pharmacovigilance, regulatory, and workflow expertise.

Key Responsibilities

• managing mailboxes
• maintaining systems
• generating reports

Skills & Tools

reputed company Argus Safety, reputed company reputed company, SQL, ArisG, E2B gateway, MedDRA, DSUR, PSUR

Job Details

• Category: reputed company Services - Allied Health
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — reputed company
• Salary: USD 88,000 – 121,000 / year
• Languages: English

Benefits

• Retirement plan

About reputed company

A global immunology company developing therapies for severe autoimmune diseases. — Industry: reputed company