LQPPV Manager

We are growing, grow with us!
Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then PharmaLex is your career choice!

PharmaLex is part of Cencora - the leading service provider for the pharmaceutical, biotech and medical device industries globally. PharmaLex is specialised in effectively designing all aspects of drugs and medical devices regulatory needs, ranging from early development and market entry to product maintenance activities.
We are looking for a new team member to join us in Tunisia as Local Person for Pharmacovigilance, to be responsible for the establishment and maintenance of the marketing authorisation holder's local pharmacovigilance system, and the performance of local Pharmacovigilance Operations.
 

LQPPV Manager (Local Qualified Person for Pharmacovigilance)

* This is a fully remote job for someone based in Tunisia with proven senior experience in Pharmacovigilance *

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

Your Profile

• 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

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.

For further information please don't hesitate to contact us
 

Agencies only by prior agreement for the specific job opportunity.