Manager, Global Risk Management and Safety Surveillance (GRMSS)
About the position
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Global Risk Management and Safety Surveillance (GRMSS) Portfolio Manager (Manager Level) is responsible for covering Pharmacovigilance (PhV) activities throughout products lifecycle management (other than Case management) for complete set-up, maintenance and closeout of programs. The position is responsible for ensuring global PhV oversight on pipeline trials, IST/IIRs, post-marketing programs and reporting requirements. The role is also responsible to streamline and standardize collaboration with Development Operations, Data Management, Regulatory Affairs, Medical Affairs and other departments as applicable, assisting with coordinating PhV responses for all compounds and products.
Responsibilities
• Lead all PhV Project start-up, maintenance and closeout activities, including, but not limited to, Safety Reporting Plan review, safety database configuration/updates, regulatory submission impact analysis, training, as applicable, for clinical trials, IST/IIRs and post-marketing programs.
• Act as GPRM point person for key departments (e.g. Dev.Ops, Med. Affairs, Data Management, Reg. Affairs, Commercial).
• Departmental support for Portfolio oversight, including during Audits and Inspections.
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
• Coordinate GPRM efforts for new NDA/MAA/Product filing regulatory tasks, using the relevant checklist, as required.
• Organize GPRM cross-department training and brainstorming sessions for new programs and/or new products.
• Act as Subject Matter Expert (SME) with Business partners, PhV service providers and other CROs.
• Coordinate the development and maintenance of the global literature search strategy for his/her assigned product(s), per procedures.
• Contribute to the preparation and revision of INCY Periodic Safety Reports, as applicable.
• Facilitate the interactions with Clinical CROs at study and product levels and ensure accuracy of the Safety elements part of the contracts/agreements with these CROs.
• Train Portfolio Managers (Associate Manager level) and other GRMSS/GPRM staff, as appropriate.
• Assist with creating procedures (e.g. SOPs, Working Instructions, Job Aids), forms and templates, in support of efficient Project Management processes.
• Ensure compliance with internal procedures, regulatory requirements, and business partner agreements to ensure inspection readiness, at all times.
• Other responsibilities, as required and assigned by Senior management.
Requirements
• Master’s degree in Science or Healthcare related discipline, or equivalent.
• Minimum of 6 years Pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
• Minimum of 2 years Project Management experience or equivalent relevant experience.
• Experience in using safety database systems (Argus experience preferred).
• Good knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
• Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
• Excellent ability to work effectively within a team environment.
• Ability to create and deliver presentations.
• Excellent verbal and written communication skills.
• Fluency in written and verbal English.
Apply tot his job
Apply To this Job
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Global Risk Management and Safety Surveillance (GRMSS) Portfolio Manager (Manager Level) is responsible for covering Pharmacovigilance (PhV) activities throughout products lifecycle management (other than Case management) for complete set-up, maintenance and closeout of programs. The position is responsible for ensuring global PhV oversight on pipeline trials, IST/IIRs, post-marketing programs and reporting requirements. The role is also responsible to streamline and standardize collaboration with Development Operations, Data Management, Regulatory Affairs, Medical Affairs and other departments as applicable, assisting with coordinating PhV responses for all compounds and products.
Responsibilities
• Lead all PhV Project start-up, maintenance and closeout activities, including, but not limited to, Safety Reporting Plan review, safety database configuration/updates, regulatory submission impact analysis, training, as applicable, for clinical trials, IST/IIRs and post-marketing programs.
• Act as GPRM point person for key departments (e.g. Dev.Ops, Med. Affairs, Data Management, Reg. Affairs, Commercial).
• Departmental support for Portfolio oversight, including during Audits and Inspections.
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
• Coordinate GPRM efforts for new NDA/MAA/Product filing regulatory tasks, using the relevant checklist, as required.
• Organize GPRM cross-department training and brainstorming sessions for new programs and/or new products.
• Act as Subject Matter Expert (SME) with Business partners, PhV service providers and other CROs.
• Coordinate the development and maintenance of the global literature search strategy for his/her assigned product(s), per procedures.
• Contribute to the preparation and revision of INCY Periodic Safety Reports, as applicable.
• Facilitate the interactions with Clinical CROs at study and product levels and ensure accuracy of the Safety elements part of the contracts/agreements with these CROs.
• Train Portfolio Managers (Associate Manager level) and other GRMSS/GPRM staff, as appropriate.
• Assist with creating procedures (e.g. SOPs, Working Instructions, Job Aids), forms and templates, in support of efficient Project Management processes.
• Ensure compliance with internal procedures, regulatory requirements, and business partner agreements to ensure inspection readiness, at all times.
• Other responsibilities, as required and assigned by Senior management.
Requirements
• Master’s degree in Science or Healthcare related discipline, or equivalent.
• Minimum of 6 years Pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
• Minimum of 2 years Project Management experience or equivalent relevant experience.
• Experience in using safety database systems (Argus experience preferred).
• Good knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
• Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
• Excellent ability to work effectively within a team environment.
• Ability to create and deliver presentations.
• Excellent verbal and written communication skills.
• Fluency in written and verbal English.
Apply tot his job
Apply To this Job