Specialist Local Pharmacovigilance Castelo Branco

Specialist Local Pharmacovigilance
Castelo Branco
Castelo Branco, Castelo Branco, Portugal

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 working with our
- class pharmaceutical partner's project. This is a
- based position that can be hired in Portugal.

• Set up and manage the local pharmacovigilance system
• Local Literature Search
• Local ICSR Management
• PV Intelligence Screening
• Setting up local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local
  - 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
• 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
• Review protocols for local studies and define PV related processes for local study projects prior to their initiation, in order to ensure compliance with the pharmacovigilance requirements and company standards

We are looking for:

• 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 Portuguese