Senior Specialist Local Pharmacovigilance
Senior Specialist Local Pharmacovigilance
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Job Description
Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
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 12 years experience as a PV Specialist/Drug Safety Associate who will be dedicated to our worldclass pharmaceutical partners project. This is a remotebased position that can be hired in Spain.
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 postauthorization safety
Participate in PVrelevant 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
Deputy is assuming responsibility in case of planned or unplanned absence
The employee agrees to take over primary listed tasks and responsibilities in other service lines project management activities as client contact point and additional reasonable tasks that align with their abilities qualification and training if required.
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National Contact Person (NCP)
Act as official liaison with the Competent Authority in the country for pharmacovigilancerelated 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 benefitrisk 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 EUQPPV and the global PV team.
Serving as point of contact to Regulatory Authorities with 24 hours availability.
The employee agrees to take over primary listed tasks and responsibilities in other service lines project management activities as client contact point and additional reasonable tasks that align with their abilities qualification and training if required.
- Minimum college level education required. A diploma or degree with a concentration in Life Sciences is a strong asset;
- 12 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.
Full timeAffiliated Companies
Affiliated Companies: PharmaLex Portugal Unipessoal Lda Pharsolution Lda)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 companys 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 nondiscriminatory.
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 . We will make accommodation determinations on a requestbyrequest basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
Senior IC
Employment Type
Full-Time
