Manager, Case Processing Oversight - United States
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|External Posting Title||Manager, Case Processing Oversight|
|Job Description||The Manager, Case Processing Oversight is responsible for the operational management and oversight of case processing activities performed internally, by the Individual Case Quality Management team, and externally, by vendors (CROs), in both the Post-Marketing and Clinical Trial settings. The Manager supports the Case Processing Oversight Associate Director and is responsible for ensuring all AE case processing is in compliance with regulatory requirements and corporate and departmental procedures.|
1. Ensures all AE case processing, in both the Post-Marketing and Clinical Trial settings, is in compliance with regulatory requirements, corporate and departmental procedure and data handling conventions by maintaining and executing oversight plans for
a. Vendors (CROs) with case processing responsibilities
2. Executes and monitors compliance through various monitoring reports and other oversight activities and ensures the implementation of effective Corrective and Preventative Action plans,
3. Acts as subject matter expert on operations and oversight of AE case processing partners during audits/inspections as necessary
4. Works with the Case Processing Oversight Associate Director to develop / review governing documents, such as SOPs, Safety Management Plans, and Safety Data Exchange Agreements, as necessary
5. Support the following partner / vendor oversight activities in relation to Case Processing:
a. Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans)
b. Support on-boarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up)
c. Provide ongoing support of partners and vendors (e.g., questions, issues, meetings)
d. Conduct partner oversight and performance management on contracted work (e.g., monitoring reports, quality evaluations, annual meetings)
|Location||Cambridge, MA, US|
|Job Category||Drug Safety|
• 4+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent
• Experience with interacting with third parties (e.g., contract service providers) preferred
• Knowledgeable in Pharmacovigilance and GCP legislation required
• Direct experience in GXP compliant quality systems preferred
• Minimum of Bachelor’s level degree in nursing, pharmacy, or other health care related profession or life sciences required
• Master’s or Doctorate level degree in health care related profession preferred
|About Biogen||Corporate Overview|
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.
We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS. As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
Biogen is revolutionizing biologics manufacturing, developing the industry’s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.
Our Corporate Citizenship
The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek’s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science’s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
Nearest Major Market: Cambridge
Nearest Secondary Market: Boston
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