RPA Project Manager (PV & Drug Safety)
Job description
Do you have experience in RPA and maintenance of a globally operated system for PV technical processes are you cup of tea?
We offer brand new opportunity in international settings!
More about great job opportunity:
- Managing the computerized Global PV System operational
- Supervising the maintenance of all Reference Data (reference tables) used by the system and the regular reconciliation of this data with other sources (e.g. BRAIN/BRAVE, Impact, PV Agreements with License partners)
- Keeping maintaining the Dictionary of all Products and Licenses including development products and licenses (maintenance of datasheets for Auto-labelling in cooperation with PV Benefit Risk Management and PV Analytics)
- Maintaining the Dictionary of all Code lists and Studies including non-company studies for which PV will have to process SAE reports (e.g. Investigator led studies)
- Responsibility for the maintenance & support of a centralized PV reporting process for EudraVigilance (inbound & outbound), all international health authorities, notified bodies and related license Partners
- Maintenance of case distribution matrix (PV Country Heads through Affiliate Module, external partners, Study teams, etc.)
- Drive, create and streamline automated PV processes on global level and keep the responsibility to build up new PV digitization solutions worldwide
- Manage centrally PV automated processes on global PV within a Center of Excellence in conjunction with support of external technical service provider
- Manager required global cross-functional PV projects and changes, including preparation and execution of change controls (like IQ, OQ, PQ) and GxP validation documentation
- Support the handover of any automated PV configuration and business procedures to related PV functions worldwide
- Share specific PV tool knowledge, implementation and query languages to implement new queries, reports and tools for risk/benefit, process, workload and impact analysis while following software development and computer system validation rules
Location: Prague
Start: ASAP
Requirements
- Master’s degree in Life Science or Computer Science
- C1 level of English language (everyday use)
- Relevant long-term years of professional experience
- Pharmacovigilance experience advantage (for ability to work with PV related data and understanding of PV drug safety processes to ensure technical PV process automation)
- Profound knowledge of global regulations and guidelines
- Detailed technical automation experiences and expertise in the maintenance of a globally operated system for Pharmacovigilance
- Experience of project management in an intercultural context, especially Eastern Europe, Middle East & Asia
- Extensive knowledge as business analyst and infrastructure engineer for technical process automation
- Extensive knowledge of process digitization technologies
- Ability to work in a very structured and accurate way
Benefits
- 6 weeks vacation
- 12 sick days
- 2 charity days
- Meal vouchers 120 CZK/day
- Bonus
- Car (personal use as well)
- Multisport card
- Notebook, mobile
- Pension & Life insurance
- Homeoffice (50:50)
Other notes