Senior Pharmacovigilance Officer

Mylan Pharma Uk Ltd ,
Hatfield, Hertfordshire
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Overview

For Us, It’s A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate.If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you. Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help: · To be responsible for the receipt, triage and Data entry/Quality review for serious events and/or adverse events of special interest as per protocol originating from Mylan sponsored global clinical trials. · Generating follow up queries and reporting/submission of clinical trial cases electronically including e2b submissions and via email. Also responsible for unblinding of cases for regulatory reporting purposes. · Managing clinical safety mailbox for incoming SAE reports on daily basis. · Periodic (Monthly/Quarterly/End of study) reconciliation of SAE’s between safety and clinical database for Mylan sponsored clinical trials by liaising with CROs and Business Partners. · Maintaining Schedule of periodic line listings in liaison with concerned CROs and provision of line listing in a timely manner to CROs for submission to various Health Authorities / Ethics Committees as required. · Highlighting issues identified (e.g. with reporting, procedures, compliance monitoring) to the Clinical Safety Manager and contributing to the development of measures to resolve them. · To be responsible for the preparation and maintenance of assigned Pharmacovigilance procedures in accordance with current regulations and company policies. · Training other team members in data entry, review and reporting for clinical trial cases when necessary. Make Our Values Your Values Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position: · To be responsible for the receipt, triage and Data entry/Quality review for serious events and/or adverse events of special interest as per protocol originating from Mylan sponsored global clinical trials. · Generating follow up queries and reporting/submission of clinical trial cases electronically including e2b submissions and via email. Also responsible for unblinding of cases for regulatory reporting purposes. · Managing clinical safety mailbox for incoming SAE reports on daily basis. · Periodic (Monthly/Quarterly/End of study) reconciliation of SAE’s between safety and clinical database for Mylan sponsored clinical trials by liaising with CROs and Business Partners. · Maintaining Schedule of periodic line listings in liaison with concerned CROs and provision of line listing in a timely manner to CROs for submission to various Health Authorities / Ethics Committees as required. · Highlighting issues identified (e.g. with reporting, procedures, compliance monitoring) to the Clinical Safety Manager and contributing to the development of measures to resolve them. · To be responsible for the preparation and maintenance of assigned Pharmacovigilance procedures in accordance with current regulations and company policies. · Training other team members in data entry, review and reporting for clinical trial cases when necessary. Why Mylan? If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care. Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran This job was originally posted as www.totaljobs.com/job/89961344

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