Pharmacovigilance Specialist Lisboa

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ALTEN Portugal, a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and
- oriented Pharmacovigilance Specialist

ALTEN Group

Within 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 Ph
V system. The role covers literature monitoring, case processing, regulatory reporting, system maintenance, and support for audits/inspections.

Key Responsibilities:

• Ph
  V System Maintenance & Governance – Maintain and update SOPs and annexes, keep the PSMF current, and provide ongoing operational support to the EU-QPPV and LQPPV.
• Literature Monitoring & Data Collection – Perform local (bibliovigilance) and global (Pub
  Med) literature searches on a weekly basis; monitor literature for safety information and extract relevant data.
• Case Safety Report Processing – Process individual case safety reports (ICSRs), including follow‑ups, narrative writing, and timely entry into the safety database in accordance with Ph
  V timelines.
• Eudra
  Vigilance Screening & Reporting – Conduct bimonthly screening and collection of cases from Eudra
  Vigilance to fulfil Ph
  V obligations and ensure data are captured for reporting.
• Regulatory Monitoring & Assessment – Perform monthly reviews of PRAC recommendations and CMDh/CHMP minutes and incorporate relevant actions into the Ph
  V plan.
• Signal Detection & Aggregated Analyses – Review signals from EVDAS and perform annual analysis of aggregated data using the Case Tracking Tool to support signal management activities.
• System & Process Quality Activities – Test safety‑related email flows twice yearly; support CAPA development and implementation following the Ph
  V system audit.
• Audit & Inspection Support – Provide Ph
  V system support during regulatory inspections and audits (internal or external), preparing documentation and responding to queries as required.

Qualifications & Experience:

• Degree 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: Portugal (Remote).

Why Join Us?

• Possibility to work with cutting‑edge technology in the Life Sciences industry
• Collaborative and dynamic work environment
• Possibility to join a top‑leading company in the industry
• Possibility to join different and interesting projects

If you want to embrace 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.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Consulting

Industries

Engineering Services, Pharmaceutical Manufacturing, and Outsourcing and Offshoring Consulting