Senior Project Lead, Global Portfolio Safety Mgmt (GPSM)

Job content

Summary

The Senior Project Lead, Global Portfolio Safety Management (GPSM) will be responsible for covering Pharmacovigilance (PhV) activities throughout Incyte products lifecycle management (other than Case management) for complete set-up, maintenance and closeout of Incyte programs. The position will be responsible for ensuring global PhV oversight on Incyte pipeline trials, IST/IIRs, post-marketing programs and reporting requirements. The role will also be responsible to streamline and standardize collaboration with Development Operations, Data Management, Regulatory Affairs, Medical Affairs and other Incyte departments as applicable, assisting with coordinating PhV responses for all Incyte compounds and products.

Duties And Responsibilities

• Lead all PhV Project start-up, maintenance and closeout activities, including, but not limited to, Safety Reporting Plan review, safety database configuration/updates, new/updated RSI distribution, regulatory/submission impact analysis, training, MedDRA upgrade, unblinding needs and EDC access request, as applicable, for clinical trials, IST/IIRs, post-marketing programs, Market Access/Research programs.
• Act as Global PhV point person for key Incyte 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 regulatory tasks, 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.
• Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources), as required.
• Train and mentor Junior Project lead(s) and other GPSM 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.
  

Requirements

• Master’s degree in a Science or Healthcare related discipline, or equivalent.
• Minimum of 6 years Pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
• Minimum of 3 years Project Management experience or equivalent relevant experience.
• Proficiency using safety database systems (Argus experience preferred).
• Advanced 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.
• Advanced organizational, time management, and problem-solving skills.
• Ability to create and deliver presentations.
• Excellent verbal and written communication skills.
• Fluency in written and verbal English.
• Travel (domestic and global) 10%.
  

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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