Local Person for Pharmacovigilance (LPPV)
- Gothenburg +3 more
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.
Your Job
- Set up and manage the local pharmacovigilance system
- Local Literature Search
- Local ICSR Management
- PV Intelligence Screening
- Local PSMF Maintenance
- Setting up local Organized Data Collection
- Local PVA Management
- Local adaptation and submission of PSUR / RMP
- Local signal detection
- Implementation of additional Risk Minimization Measures
- Reviewing materials relating to local post-authorization safety
- Integrated first Level Medical Information and PQC Support
- Participate in PV-relevant audits and inspections
- Attend regular meetings according to project meeting schedule
- Provide monthly PV report on status of local PV system in the country/ies
- Ensure PV training of affiliate employees, service providers and Third Parties
- Act as primary contact for PV for Competent Authority in the Territory, including 24/7 availability if legally required.
- Interface between the EU-QPPV / Global PV team at client and the local regulatory authority
- Close cooperation with the global PV system of the client as well as related global and local departments and functions
- Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
- Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
- Deputy is assuming responsibility in case of planned or unplanned absence
Skills & Requirements
- University degree in Medicine, Pharmacy or Life Science
- Several years’ experience and profound knowledge in the field of pharmacovigilance
- Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilance
- Detailed knowledge of related SOPs (global and local)
- Participation in all relevant courses of instruction such as internal trainings and applicable external courses
- Experience in all operative tasks that are performed by the members of the pharmacovigilance department
- Familiarity with industry principles of pharmacovigilance
- Ability to organise operational procedures and mange different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)
- Ability to adjust rapidly to new, unknown, challenging situations
- Ability to analyse and solve problems and to develop possible solutions
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Very good command of English
About the company
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 development to market and any action of effective product maintenance. PharmaLex values includes international mindset, growth & learning, collaboration, quality focus, dynamic working approach and integrity & respect.
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