Job Description
The Opportunity:
Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality, you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products.
This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid
The Role:
- Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to , governance, financials, contracts, quality and training, and resourcing.
- Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
- Oversee case management vendor(s) to manage and resolve emerging issues.
- Develop and/or maintain/ update existing documents for relevant vendor responsibilities.
- Contributes ICSR quality strategy.
- Responsible for Global ICSR Reconciliation activities.
- Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required.
Your Skills & Abilities:
- BS/BA, RN, Pharmacist, or equivalent.
- Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
- Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
- Experience working with third parties (e.g., contract service providers) and relationship management.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
The Opportunity:
Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality, you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products.
This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid
The Role:
- Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to , governance, financials, contracts, quality and training, and resourcing.
- Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
- Oversee case management vendor(s) to manage and resolve emerging issues.
- Develop and/or maintain/ update existing documents for relevant vendor responsibilities.
- Contributes ICSR quality strategy.
- Responsible for Global ICSR Reconciliation activities.
- Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required.
Your Skills & Abilities:
- BS/BA, RN, Pharmacist, or equivalent.
- Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
- Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
- Experience working with third parties (e.g., contract service providers) and relationship management.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
About CSL
For over a century, we’ve been an unstoppable force, from developing medicines that save and improve lives to vaccines that protect them. Today, with the combined expertise of CSL Behring (with oversight to CSL Plasma), CSL Seqirus, and CSL Vifor—and our singular commitment to relentlessly innovate—CSL’s offerings are more diverse than ever to help ensure patients and people everywhere get the treatments they deserve. We’re always improving so life can, too.
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