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The Local Person for Pharmacovigilance 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
The tasks assigned will be in line with the responsibilities in scope of the various projects as defined in the section Functional/Project roles of this RD.
· 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
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 timeCencora 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