Sr Associate II, Drug Safety - United States
|External Posting Title||Sr Associate II, Drug Safety|
|Job Description||The Data Handling and Process Standardization Safety Associate supports the ICSR Processes & Submissions Associate Director and is responsible for supporting the implementation of the strategy and standards for Case Processing as well as processes and conventions for data handling. These standards and processes are necessary for day-to-day operations, and appropriate monitoring of the safety profile of Biogen’ s products through Pharmacovigilance activities including evaluation, processing, and follow-up on adverse event reports. Other key responsibilities include providing inspection support, developing training materials and conducting User Acceptance testing to support Safety Database maintenance, assisting with ICSR submission activities and quality and compliance adherence. |
1. Support the ICSR Processes & Submissions Associate Director with the implementation of the strategy and standards for Case Processing as well as the conventions for data handling
a. Ensure standards and processes are compliant with regulatory and Biogen requirements
2. Support ICSR Processes & Submissions Associate Director in the development and maintenance of:
a. SOPs and processes for Case Processing
b. Metrics and KPIs
3. Develop Training materials for Case Processing
4. Develop and deliver training for the Global Safety Database for SABR Team members
5. Conduct User Acceptance Testing to support Global Safety Database Maintenance
6. Provide support during inspections, including inspection readiness, SME Support, and ensuring fulfillment of any regulatory commitment related to Case Processing
7. Work with the Quality & Compliance team to ensure adherence to quality and compliance standards / requirements
|Location||Cambridge, MA, US|
|Job Category||Drug Safety|
• 2+ years in a clinical setting (preferred but not required)
• 3+ years in Drug Safety department in pharmaceutical / biopharmaceutical industry
• Proven ability to evaluate clinical data
• Familiarity with GCP and Safety regulations
• Excellent communication skills
• Ability to handle multiple priorities
• Ability to solve complex problems
• Able to effectively communicate orally and in writing
• Able to produce clear, concise documentation
• Able to interact collaboratively in a team environment
• Ability to interpret regulations and apply the interpretation to departmental SOPs and guidelines
|Education||Minimum of Bachelor's level degree in nursing, pharmacy, or other health related profession or alternatively a Bachelor’s level degree in life sciences|
|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.
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.
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.
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