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Job Details
Responsibilities:
Set up and manage the local pharmacovigilance system, including oversight of local PV activities.
Local Literature Search
Local ICSR Collection and Management
PV Intelligence Screening
Local PSMF Maintenance (where applicable)
Setting up Local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP (where applicable)
Local signal detection (where applicable)
Implementation of additional Risk Minimization Measures
Reviewing materials relating to local post-authorization safety studies
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
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
Identify and escalate any Medical Information requests to an appropriate team according to applicable timelines.
24/7 availability with the Competent Authority in the country for pharmacovigilance-related matters.
Act as official liaison with the Competent Authority in the country for pharmacovigilance-related matters.
Maintain oversight of local PV system to ensure compliance with national laws and regulations.
Notify the health authority promptly of significant safety concerns, product recalls or changes in the benefit-risk profile of the products.
Coordinate the distribution of national safety communications, such as Direct Healthcare Professional Communications.
Ensure local pharmacovigilance system updates and validations.
Internally, serving as point of contact for the EU-QPPV and the global PV team.
Deputy is assuming responsibility in case of planned or unplanned absence
.
Qualification & Experience required:
Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required.
2+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required.
Certification in regulatory affairs, quality management, compliance, auditing preferred.
English business fluent & local language
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
Affiliated Companies: PharmaLex Spain S.L.U.
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
[email protected]
. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned