Job Summary (Primary function)
The Global Risk Management and Safety Surveillance (GRMSS) Portfolio Manager (FSP) 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 Incyte compounds and products.
Essential Functions of the Job (Key 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, 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 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.
- 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.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- 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 2 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.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
