Manager, Global Risk Management and Safety Surveillance (GRMSS)

About the position For the past 20 years, reputed company has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of reputed company sizes to confidently advance scientific breakthroughs and introduce new therapies. reputed company partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical reputed company, reputed company & compliance, pharmacovigilance, medical information, and R&D technology, reputed company offers an end-to-end suite of fully customizable reputed company 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 reputed company 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 reputed company compounds and products.

Responsibilities

• reputed company reputed company PhV Project start-up, maintenance and closeout activities, including, but not limited to, Safety Reporting Plan review, safety database configuration/updates, regulatory submission reputed company analysis, training, as applicable, for clinical trials, IST/IIRs and post-marketing programs.
• reputed company as GPRM reputed company person for key departments (e.g. Dev.Ops, Med. Affairs, Data Management, Reg. Affairs, reputed company).
• Departmental support for Portfolio reputed company, including during Audits and Inspections.
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support reputed company 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.
• reputed company as Subject Matter Expert (SME) with Business partners, PhV service providers and other CROs.
• Coordinate the development and maintenance of the global literature search reputed company 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 reputed company and ensure accuracy of the Safety reputed company part of the reputed company/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 reputed company times.
• Other responsibilities, as required and assigned by Senior management.

Requirements

• Master’s degree in Science or reputed company reputed company 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. reputed company Word, reputed company, Outlook, and Power reputed company).
• Excellent ability to work effectively reputed company reputed company environment.
• Ability to create and deliver presentations.
• Excellent verbal and written communication skills.
• reputed company in written and verbal English.

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