Associate Director Global Patient Safety
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Working from Home
- Start date
- Nov 25, 2022
View more
- Discipline
- Administration, Clinical, Manufacturing & Production
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Responsible for providing medical assessment and oversight of individual case safety reports completed by vendors and case processing resources in accordance with applicable regulations and agreements.
Responsible for ensuring that assigned staff are appropriately prepared to support current and anticipated activities for medical review and assessment of reports from global development programs and globally marketed products.
Responsible for ensuring inspection readiness and monitoring quality of the medical aspects of PV results. Incumbent may have an encouraging role in audits and health authority inspections
A typical day in this role might be like...
- Review all high impact cases (e.g. fatal/life threatening SUSARs, unanticipated events, cases where investigator and company causality differ, and others as required) prior to submission to health authorities.
- Provide medical advice and input to the activities of adverse event (AE) case management, including medical review of ICSRs (narrative, coding, labeling, causality, company comment) as well as work closely with PV teams, RM leads and clinical development leads to provide a cohesive, comprehensive and accurate medical narrative, analysis of similar events (when applicable) and company causality rationale in individual case reports prior to health authority submission.
- Ability to apply and provide critical analysis of relevant clinical information for both clinical trial and post-marketing SAE and AESIs. Function as a medical review expert internal and external to PVRM for Regeneron compounds. Ability to apply PVRM safety database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) medical rationale and defend recommendations in safety narratives.
- MD required
- Clinical experience, with 5 + years of industry experience in pharmacovigilance/ drug safety including significant previous experience in medical review of individual cases.
#GDPSJobs
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually)
$145,200.00 - $237,000.00Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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