Pharmacovigilance Specialist

ALTEN Portugal, a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and detail-oriented Pharmacovigilance SpecialistALTEN GroupWithin 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?We are looking for a Pharmacovigilance Specialist to support the maintenance and operation of the PhV system. The role covers literature monitoring, case processing, regulatory reporting, system maintenance, and support for audits/inspections.Key ResponsibilitiesPhV System Maintenance & GovernanceMaintain and update SOPs and annexes, keep the PSMF current, and provide ongoing operational support to the EU-QPPV and LQPPV.Literature Monitoring & Data CollectionPerform local (bibliovigilance) and global (PubMed) literature searches on a weekly basis; monitor literature for safety information and extract relevant data.Case Handling & ICSR ManagementProcess individual case safety reports (ICSRs), including follow-ups, narrative writing, and timely entry into the safety database in accordance with PhV timelines.EudraVigilance Screening & ReportingConduct bimonthly screening and collection of cases from EudraVigilance to fulfil PhV obligations and ensure data are captured for reporting.RPS (PSUR/Risk Management) Calendar & SubmissionsReview the RPS scheduling in light of EURD list updates and prepare and submit required RPS documentation to authorities.Regulatory Monitoring & AssessmentPerform monthly reviews of PRAC recommendations and CMDh/CHMP minutes and incorporate relevant actions into the PhV plan.Signal Detection & Aggregated AnalysesReview signals from EVDAS and perform annual analysis of aggregated data using the Case Tracking Tool to support signal management activities.System & Process Quality ActivitiesTest safety-related email flows twice yearly; support CAPA development and implementation following the PhV system audit.Audit & Inspection SupportProvide PhV system support during regulatory inspections and audits (internal or external), preparing documentation and responding to queries as required.Qualifications & ExperienceDegree in in a Pharmaceutical-related field.Minimum of 3 years’ experience in pharmacovigilance or drug safety (industry or CRO preferred).Strong analytical skills, attention to detail, and excellent written communication.Excellent communication, organization, and problem-solving skills.Location: Lisbon, Portugal (Hybrid).Why Join Us?Possibility to work with cutting-edge technology in the Life Sciences industryCollaborative and dynamic work environmentPossibility to join a top-leading company in the industryContinuous trainingsPossibility to join different and interesting projectsIf you want to embrace in a new and challenging opportunity and are excited about the opportunity to contribute to our team, we want to hear from you! Please submit your resume and cover letter detailing your relevant experience and qualifications.