We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Associate Director Pharmacovigilance IT Solutions
- Collaboration in designing the strategy for the coordinated service Digital Solutions in Pharmacovigilance with the Heads of department
- Communication and implementation of decisions of the Heads in the coordinated service area
- Representation of the service and tools to stakeholders, including support during PV audits and inspections
- Take over responsibility for planning, managing and feasibility of projects within the coordinated service area
- Setup, maintenance and development of technology enabled system services / PharmaLex’ technology solutions within the Pharmacovigilance department
- Economic steering and monitoring of all projects within the coordinated service area, including safety database and data migration projects
- Ensure and maintain computer system validation status of relevant systems
- Coordination of an international team to ensure internal support for relevant computerized systems
- Optimization of processes regarding the coordinated service, including process ownership and currentness of related SOPs
- Master’s Degree in life sciences
- At least three years of experience in pharmacovigilance and related aspects
- Ideally the candidate should have worked for a PV service provider on different client projects or in a corporate PV department with exposure to relevant PV/project management tasks
- Experience in managing computerized systems (e.g. maintenance of PV safety databases), including vendor management
- Experience in computer system validation processes, and data migration projects
- Experience in participating audits and inspections
- Coordination of and working with international teams, ideally in virtual environments
- Knowledge of the applicable legislation (e.g. GVP)
- Knowledge of computer system validation procedures and legislation (e.g. 21 CFR Part 11, EudraLex Volume 4 Annex 11, GAMP5)
- Knowledge of Pharmacovigilance Safety Databases
- Ideally, knowledge of PV system structures and principles
- Project management experience
- Very good command of English language
- Very good knowledge of MS Office applications
- Ideally, an understanding of software development processes, programming and databases
- Team player
- Ability to adjust rapidly to new, unknown, challenging situations
- High affinity to technology, and a strong determination to learn new applications
- Structured, solution-oriented and independent working style
- Initiative and decision-making ability
- Willingness to take responsibility
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.