About This Role
As Senior Pharmacovigilance (PV) Scientist, you will serve as a product lead for PV activities within Safety. In this role, you will be responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. You will also serve as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information. In this capacity, your role as Sr. PV Scientist is critical to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.
What You’ll Do
Major Accountabilities include:
Lead the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluate safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Lead signalling review process and product Safety Signalling Team meetings. Manage literature review for safety information.
Lead the process for responding to safety questions from regulatory authorities.
Lead Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
Collaborate with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, ad hoc requests and other product activities, as assigned.
Who You Are
You are a passionate and experienced PV Scientist with signal management and RMP experience, who brings strong problem-solving capabilities and enthusiasm to the role.
Qualifications
Required Skills Bachelor’s Degree in biologic or natural science, or health care discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required. Significant and proven Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management. Ability to understand, interpret, analyse, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology). Lead and conduct, independently and/or collaboratively, all aspects of substantive projects such as signalling, authoring of aggregate data reports, and responses to regulatory agency requests. Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts. Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems. Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues. Applies clinical judgment to interpret case information. Strong organizational skills, including the ability to prioritize independently with minimal supervision. Additional Information
Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
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Required Skills Bachelor’s Degree in biologic or natural science, or health care discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required. Significant and proven Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management. Ability to understand, interpret, analyse, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology). Lead and conduct, independently and/or collaboratively, all aspects of substantive projects such as signalling, authoring of aggregate data reports, and responses to regulatory agency requests. Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts. Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems. Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues. Applies clinical judgment to interpret case information. Strong organizational skills, including the ability to prioritize independently with minimal supervision. Additional Information
Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
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