Regenxbio
Senior Director, Head of Pharmacovigilance
Regenxbio, Potomac, Maryland, United States, 20854
Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The opportunity
You will be responsible for providing oversight and management of all activities pertaining to product safety and pharmacovigilance in clinical development and post-marketing surveillance. You will ensure that appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for REGENXBIO products, are globally completed. This includes oversight of all safety activities, including those performed by external suppliers, for REGENXBIO.
What you'll be doing
Advance and maintain the safety governance oversight for all REGENXBIO products
Build and manage a high-growth pharmacovigilance team, including recruitment, training, assessment, monitoring and development. Communicate company/departmental information effectively to team.
Provide global strategic leadership by setting clear expectations & providing hands-on leadership for PV, promoting collaboration and team cohesiveness.
Oversee all PV-related activities performed by external suppliers/consultants, ensuring appropriate documentation and governance frameworks are in place
Interact with internal and external staff to develop programs and processes to meet regulatory reporting requirements.
Lead process improvement within global pharmacovigilance – including technology assessment and implementation.
Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including review of clinical study protocols, development plans, INDs/CTAs and serious adverse event handling and all other PV issues, as appropriate.
Oversee aggregate reporting, management of risk-benefit profiles, signal detection and risk management and mitigation plans for clinical and post-marketing compounds.
Directly oversee the PV staff and operations (including external resources) globally to ensure high quality case processing and aggregate reporting consistent with quality performance metrics.
Successfully plan and forecast for global resources and PV budget and partner with other groups on resource needs (e.g., medical organization for writing and statistical staffing; medical affairs for epidemiology project needs).
Implement global process standardization and improvement.
Provide safety expertise to other REGENBIO departments and functions.
Ensure PV staff are able to meet safety monitoring needs based on regulatory requirements and company standards for pharmacovigilance and are audit-ready.
Represent PV in audits with health authorities and development partners.
Oversee development of training modules and provide training in Pharmacovigilance across the Company.
Oversee aggregate medical review and signal detection/analysis activities for the REGENXBIO product portfolio.
Ensure compliance of operations with governing regulatory requirements.
It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
What we're looking for
MD degree or equivalent
At least 12 years of pharmaceutical industry experience, including at least 5 years in pharmacovigilance management roles
2 – 3 years of clinical practice experience preferred
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.
We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!
In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.
#J-18808-Ljbffr
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The opportunity
You will be responsible for providing oversight and management of all activities pertaining to product safety and pharmacovigilance in clinical development and post-marketing surveillance. You will ensure that appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for REGENXBIO products, are globally completed. This includes oversight of all safety activities, including those performed by external suppliers, for REGENXBIO.
What you'll be doing
Advance and maintain the safety governance oversight for all REGENXBIO products
Build and manage a high-growth pharmacovigilance team, including recruitment, training, assessment, monitoring and development. Communicate company/departmental information effectively to team.
Provide global strategic leadership by setting clear expectations & providing hands-on leadership for PV, promoting collaboration and team cohesiveness.
Oversee all PV-related activities performed by external suppliers/consultants, ensuring appropriate documentation and governance frameworks are in place
Interact with internal and external staff to develop programs and processes to meet regulatory reporting requirements.
Lead process improvement within global pharmacovigilance – including technology assessment and implementation.
Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including review of clinical study protocols, development plans, INDs/CTAs and serious adverse event handling and all other PV issues, as appropriate.
Oversee aggregate reporting, management of risk-benefit profiles, signal detection and risk management and mitigation plans for clinical and post-marketing compounds.
Directly oversee the PV staff and operations (including external resources) globally to ensure high quality case processing and aggregate reporting consistent with quality performance metrics.
Successfully plan and forecast for global resources and PV budget and partner with other groups on resource needs (e.g., medical organization for writing and statistical staffing; medical affairs for epidemiology project needs).
Implement global process standardization and improvement.
Provide safety expertise to other REGENBIO departments and functions.
Ensure PV staff are able to meet safety monitoring needs based on regulatory requirements and company standards for pharmacovigilance and are audit-ready.
Represent PV in audits with health authorities and development partners.
Oversee development of training modules and provide training in Pharmacovigilance across the Company.
Oversee aggregate medical review and signal detection/analysis activities for the REGENXBIO product portfolio.
Ensure compliance of operations with governing regulatory requirements.
It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
What we're looking for
MD degree or equivalent
At least 12 years of pharmaceutical industry experience, including at least 5 years in pharmacovigilance management roles
2 – 3 years of clinical practice experience preferred
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.
We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!
In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.
#J-18808-Ljbffr