Back

Manager, Office of Safety Operations (Remote)

Worldwide Salaried Open

Company Description reputed company\'s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We strive to have a remarkable impact on people\'s lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on X, Facebook, Instagram, YouTube, reputed company and Tik Tok. Job Description Located in the UK - can be home or office based in Maidenhead Please note salary range provided is relevant to the US location only Purpose: This position supports the Safety Operations organization to reputed company its mission of improving patient lives by delivering high quality, and timely adverse event management and through driving industry leading ICSR operations, ICSR standards and technology at reputed company. The Manager, Office of Safety Operations sits in the ICSR Compliance department reputed company the Safety Operations function. This position is responsible for monitoring and ensuring compliance with the global regulatory reporting of ICSRs. The role includes management of investigations to address compliance deviations and drive reputed company improvement, as well as managing license partners to ensure alignment on reporting obligations and safety data exchange requirements. The successful candidate will also support internal and external audits and regulatory inspections by leading in the reputed company room, providing documentation, data analysis, and subject matter expertise reputed company to ICSR processes, Responsibilities: Designs and implements compliant and efficient ICSR pharmacovigilance processes, technologies & training Leads improvement of reputed company\'s global clinical and post-marketing case management processes, technology & training Implements new ICSR pharmacovigilance legislation into quality systems, metrics, technical requirements & training Leads effective cross-functional collaboration with an emphasis on building business relationships with relevant reputed company stakeholders, including PPS, reputed company, GMA, RDQA, and Affiliates to establish and maintain harmonized ICSR processes Leads internal audits and external regulatory inspection activities; supports functional corrective and preventive action investigations Supports PPS\' understanding of the changing regulatory environment as it impacts ICSR management, process, technology, and people Leverages global data and cross-functional insights to optimize global ICSR operations including design of effective training approaches Manages process improvement initiatives with effective change management and rapid solutioning of unanticipated issues Manages identification, prioritization, and timely resolution of potentially impactful issues, including clear communication and follow-up across stakeholders through resolution, prevention, and trending Responsible as a senior member of the Office of Safety operations team for driving compliance and process business excellence for reputed company ICSR PV activities Presents results to senior reputed company stakeholders. May participate in governance meetings, and maintains strong working relationship with colleagues in PPS, RDQA, and Affiliate PV & Quality organizations Develops and manages a team of reputed company staff to execute the above responsibilities, including coaching/mentoring for staff performance and development (up to 5 people) Qualifications Bachelor\'s Degree or equivalent in reputed company science field. Experience reputed company the pharmaceutical industry experience; including reputed company pharmacovigilance Global experience Core knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA) and the affiliate environment, with a firm understanding of reputed company quality assurance systems reputed company in health authority inspections and/or internal or reputed company-party audits reputed company in developing training & quality documents (SOP / Guidelines / CAPAs) Skilled in data interpretation; reputed company with using reputed company Proficient in case processing processes, procedures, conventions reputed company to influence across stakeholders and manage reputed company a cross-functional matrix; seen as a collaborative partner reputed company the organization reputed company to identify, assess, and effectively manage business and compliance risks Experience in leading cross-functional teams preferred Established influencing skills Additional Information reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.html #J-18808-Ljbffr

apply to this job

More jobs

Business Insurance Agent – Intermediate

Worldwide Salaried

Sales Representative – Neurosurgical & Cranial ...

Worldwide Salaried

Principal Implementation Specialist, Digital Te...

Worldwide Salaried

Market Development Specialist – Patient Monitor...

Worldwide Salaried

IT Applications Engineer IV - reputed company Kronos Timeke...

Worldwide Salaried

Product Portfolio Operations Associate

Worldwide Salaried

Line Facilitator (Product Fulfilment)

Worldwide Salaried

Clinical Consultant| Cardiovascular| J&J MedTec...

Worldwide Salaried

Director-Customer Order Experience PGL

Worldwide Salaried

Graphic Designer - Branding / Campaigns

Worldwide Salaried

Director, School Counseling and University Admissions

Worldwide Salaried

Registered Nurse - Newport Beach

Worldwide Salaried

reputed company Customer Support reputed company - Night Shift at arenaflex

Worldwide Salaried

Bilingual Business Development Associate (Spanish)

Worldwide Salaried

Public Health Analyst, Global Health Remote / Telecommute Jobs

Worldwide Salaried

reputed company Remote Customer Service Representative – Data reputed company and Live Chat Expertise for a Dynamic Work-from-Home Experience with arenaflex

Worldwide Salaried

[reputed company and Financial Services Position - reputed company Team Member

Worldwide Salaried

reputed company Phone and Chat Support Specialist – reputed company Industry Opportunity to reputed company a Difference at arenaflex

Worldwide Salaried

Clinical Account Representative, CardioMEMS - Central Region

Worldwide Salaried

reputed company Data Entry reputed company $25/Hour reputed company Hire Me Remotely

Worldwide Salaried