Senior Specialist Local Pharmacovigilance

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Job Details Pharmalex is recruiting for a talented Sr PV Specialist to join our team in Portugal!
We are looking for a fluent Portuguese speaker with 1-2 years experience as a PV Specialist/Drug Safety Associate who will be dedicated to our world-class pharmaceutical partner's project.
This is a remote-based position that can be hired in Spain.

Responsibilities: 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 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 National Contact Person (NCP): 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.
Serving as point of contact to Regulatory Authorities with 24 hours availability.
Minimum Requirements: Minimum college level education required.
A diploma or degree with a concentration in Life Sciences is a strong asset; 1-2 years experience in Medical Information, Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields; Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH; Adaptability to change and to learn new skills as required; Experience in the medical and/or pharmaceutical field(s), medical terminology is an asset; Fluency in English and Spanish 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.

Affiliated Companies: PharmaLex Portugal Unipessoal Lda (= Pharsolution Lda)
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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.

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If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email We will make accommodation determinations on a request-by-request basis.
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