Global Patient Safety Lead
3 weeks ago
The Senior Manager of Global Patient Safety will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position will be responsible for safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.
Key Responsibilities
- Complete signal detection activities in line with approved safety surveillance plans
- Perform signal evaluation for any identified signals and author safety evaluation reports
- Manage preparation and review of safety documents, including DSUR, PSUR, RMP, and responses to health authority queries
- Prepare and deliver presentations at Signal Management Team meetings and participate in clinical study team meetings for assigned compounds
- Participate in other risk management activities as appropriate for assigned compounds
- Represent the Global Patient Safety team on cross-functional teams, including Regeneron Safety Oversight Committee and Independent Data Monitoring Committees
- Actively participate in process improvement initiatives, such as the development and maintenance of relevant SOPs, WIs, and supporting documents
Requirements
- Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
- Ability to work with a safety system database for purposes of medical case review and simple queries
- Proactive and self-disciplined, with the ability to meet deliverables and effectively use time and prioritize
- Ability to effectively communicate safety findings, both verbally and in writing
Education and Experience
- Minimum Master's, PhD, or PharmD degree
- 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority
About Regeneron
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan, or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications, etc.
Salary Range (annually): $145,400.00 - $237,200.00
-
Global Patient Safety Lead
6 days ago
Uxbridge, United Kingdom Pharmiweb Full timeJob Title:Global Patient Safety LeadDescription:The Global Patient Safety Lead role is the primary point of contact for all safety-related issues within a given therapeutic area. This role serves as the first point of contact for all safety-related issues, collaborating with cross-functional teams and external stakeholders to deliver the safety strategy....
-
Global Patient Safety Lead
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryThe Senior Manager of Global Patient Safety will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position requires a strong understanding of pharmacovigilance activities and the ability to apply relevant FDA, EU, and ICH guidelines.Key...
-
Director of Global Patient Safety
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryThe Director of Global Patient Safety will serve as the first point of contact for all safety-related issues for assigned compounds within a given therapeutic area. This role requires the ability to work with and influence colleagues in a matrix environment, including senior management. The successful candidate will lead the safety strategy and...
-
Director of Global Patient Safety
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryWe are seeking a highly experienced and skilled Director of Global Patient Safety to join our team at Regeneron. As a key member of our organization, you will be responsible for leading our global patient safety efforts and ensuring the highest standards of safety and compliance across all our operations.Key ResponsibilitiesDevelop and implement...
-
Senior Lead in Global Patient Safety
1 week ago
Uxbridge, United Kingdom Pharmiweb Full timeJob Description:Regeneron is recruiting a highly skilled professional to fill the role of Senior Lead in Global Patient Safety. This pivotal position is part of Regeneron's Global Patient Safety organization, specifically in the Case Evaluation & Reporting area. We seek an individual who will coordinate pharmacovigilance operations, ensuring efficient...
-
Global Patient Safety Scientist Lead
3 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeJob SummaryWe are seeking a highly skilled Senior Manager of Global Patient Safety to join our team. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety of our patients and products.Key ResponsibilitiesDevelop and implement safety strategies for molecules in clinical development and post-marketing...
-
Director of Global Patient Safety Sciences
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryThe Director of Global Patient Safety Sciences will serve as the first point of contact for all safety-related issues for assigned compounds within a given therapeutic area. This role requires the ability to work with and influence colleagues in a matrix environment, including senior management. The Director will lead the safety strategy and...
-
Associate Director, Global Patient Safety Lead
1 month ago
Uxbridge, United Kingdom Pharmiweb Full timeJob Title: Associate Director, Global Patient SafetyRegeneron is seeking an experienced Associate Director to join our Global Patient Safety team. As a key member of our organization, you will play a pivotal role in ensuring the efficient processing of pharmacovigilance operations, meeting regulatory standards, and maintaining inspection readiness.Key...
-
Associate Director, Global Patient Safety Lead
1 month ago
Uxbridge, United Kingdom Pharmiweb Full timeJob Title: Associate Director, Global Patient SafetyRegeneron is seeking an experienced Associate Director to join our Global Patient Safety team. As a key member of our organization, you will play a pivotal role in ensuring the efficient processing of pharmacovigilance operations, meeting regulatory standards, and maintaining inspection readiness.Key...
-
Director of Global Patient Safety Sciences
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Summary: We are seeking a highly skilled Director of Global Patient Safety Sciences to lead our safety strategy and operations. The successful candidate will serve as the first point of contact for all safety-related issues and will be responsible for ensuring the optimal support from within our Global Patient Safety organization.Key...
-
Global Patient Safety Lead
3 weeks ago
Uxbridge, United Kingdom BTA Full timeThe Senior Manager of Global Patient Safety will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.Key...
-
Senior Manager, Global Patient Safety Lead
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryWe are seeking a highly experienced Senior Manager, Global Patient Safety to lead our Intake and ICSR submission processes. This role will be responsible for ensuring compliance with global regulations and contractual obligations.Key ResponsibilitiesLead the Intake process for adverse event data and ICSR submissionsDevelop and implement processes...
-
Global Patient Safety Director
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryRegeneron is seeking an experienced professional to fill the role of Associate Director in Global Patient Safety. This position is a pivotal role within Regeneron's Global Patient Safety organization, specifically in the Case Evaluation & Reporting area. The ideal candidate will have a strong understanding of pharmacovigilance operations and be...
-
Director of Global Patient Safety Operations
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeRegeneron Seeks Associate Director in Global Patient SafetyRegeneron is a leading biotech company seeking an experienced Associate Director to join its Global Patient Safety organization. This pivotal role will coordinate pharmacovigilance operations, ensuring efficient vendor and case processing to meet regulatory standards.Key Responsibilities:Coordinate...
-
Director of Global Patient Safety Operations
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeRegeneron Seeks Associate Director in Global Patient SafetyRegeneron is a leading biotech company seeking an experienced Associate Director to join its Global Patient Safety organization. This pivotal role will coordinate pharmacovigilance operations, ensuring efficient vendor and case processing to meet regulatory standards.Key Responsibilities:Coordinate...
-
Senior Manager, Global Patient Safety
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Manager, Global Patient Safety to join our team at Regeneron. As a key member of our Global Patient Safety team, you will be responsible for leading the initial intake of adverse event data and subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities,...
-
Senior Manager, Global Patient Safety
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Manager, Global Patient Safety to join our team at Regeneron. As a key member of our Global Patient Safety team, you will be responsible for leading the initial intake of adverse event data and subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities,...
-
Global Patient Safety Director
6 days ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryRegeneron is seeking a highly skilled Associate Director in Global Patient Safety to lead our Case Evaluation & Reporting area. This pivotal role requires a talented individual to coordinate pharmacovigilance operations, ensuring efficient vendor and case processing to meet regulatory standards. You will play a key role in inspection readiness,...
-
Uxbridge, United Kingdom Pharmiweb Full timeJob Title: Senior Director of Global Patient Safety OperationsAt Pharmiweb, we are seeking a highly skilled Senior Director of Global Patient Safety Operations to join our team. As a key member of our Global Patient Safety organization, you will play a pivotal role in ensuring the efficient processing of pharmacovigilance operations, meeting regulatory...
-
Senior Manager, Global Patient Safety Expert
4 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Patient Safety Scientist to join our team. As a key member of our Global Patient Safety team, you will play a critical role in ensuring the safety of our patients and products.Key ResponsibilitiesDevelop and implement safety strategies for molecules in clinical development and post-marketing...
