Role purpose
The Local Person for Pharmacovigilance in TUNISIA is responsible for the establishment and maintenance of the marketing authorisation holder's local pharmacovigilance system, and the performance of local Pharmacovigilance Operations.
Main tasks
- 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
- Details on local PV operations delegated are included in project-specific Working Practices per client project.
- In general: 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.
Qualifications
- Bachelor's degree in pharmacy, pharmaceutical sciences, life sciences, or a related field, or equivalent experience required.
- Master's degree in pharmacy, pharmaceutical sciences, life sciences, or a related field, or equivalent experience preferred.
- 7+ years of experience in drug safety, pharmacovigilance, pharmacy operations, or a related field required.
- 3+ years of experience in a management capacity required.
- Certification in project management, quality management, or pharmacovigilance preferred.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies
PharmaLex GmbH
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned.
About Cencora
Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.
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Pharmacovigilance Specialist Arbeitgeber: PharmaLex GmbH
Pharmalex bietet eine dynamische Arbeitsumgebung, in der Sie täglich neue Herausforderungen und Chancen erleben können. Als führendes Dienstleistungsunternehmen in der Pharmaindustrie fördern wir eine Kultur der Zusammenarbeit und des Wachstums, die es unseren Mitarbeitern ermöglicht, sich kontinuierlich weiterzuentwickeln. Unsere Mitarbeiter profitieren von flexiblen Arbeitszeiten, einem unterstützenden Team und der Möglichkeit, an bedeutenden Projekten zu arbeiten, die einen echten Einfluss auf die Gesundheit der Menschen haben.
