Grow with Us!
Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? PharmaLex is your career choice! As part of Cencora, we are a leading service provider for the pharmaceutical, biotech, and medical device industries globally, specializing in regulatory needs from early development and market entry to product maintenance.
This is a fully remote position for candidates based in Tunisia with proven senior experience in pharmacovigilance.
System Management:
Set up and manage the local pharmacovigilance system, ensuring compliance with regulations.
Literature and ICSR Management:
Conduct local literature searches and manage Individual Case Safety Reports (ICSRs).
PV Intelligence Screening:
Screen for relevant pharmacovigilance intelligence and maintain the local Pharmacovigilance System Master File (PSMF).
Data Collection and Management:
Organize local data collection and manage the local Pharmacovigilance Assessment (PVA).
Reporting:
Adapt and submit Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs), and perform local signal detection.
Risk Management:
Implement additional Risk Minimization Measures and review materials related to post-authorization safety.
Support and Training:
Provide integrated first-level medical information and PQC support, and ensure PV training for affiliate employees and service providers.
Audit Participation:
Participate in PV-relevant audits and inspections, and attend regular project meetings.
Primary Contact:
Act as the primary contact for PV with the Competent Authority in the territory, ensuring 24/7 availability if legally required.
Collaboration:
Work closely with the EU-QPPV, the global PV team, and local regulatory authorities, ensuring effective communication and compliance.
Education:
University degree in Medicine, Pharmacy, or Life Sciences.
Experience:
Several years of experience and profound knowledge in pharmacovigilance.
Regulatory Knowledge:
Expertise in relevant global and local legislative guidelines, along with detailed knowledge of SOPs.
Operational Skills:
Familiarity with the operational tasks of the pharmacovigilance department and the ability to manage multiple tasks simultaneously.
Adaptability:
Ability to adjust rapidly to new and challenging situations.
Analytical Skills:
Strong problem-solving abilities to analyze issues and develop solutions.
Team Player:
Autonomous, focused, and capable of high-quality work, with a strong sense of responsibility.
Language Skills:
Very good command of English.
If you are interested in joining the Pharmalex team for this exciting opportunity, please submit your application, including your earliest possible starting date, any visa requirements, and salary expectations. We look forward to hearing from you!
Note: Agencies should contact us only with prior agreement regarding this specific job opportunity.
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Canada |Quebec :
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Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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