Enter a job title or keyword
Regulatory Affairs & Pharmacovigilance Manager
Job Location:
Job Location:
Matosinhos - Portugal
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
22 October 2026 (3 days ago)
Posted:
Application Deadline:
19 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
We are seeking a Regulatory Affairs & Pharmacovigilance Manager to lead our RA/PV team and ensure regulatory compliance and robust patient-safety systems across our clinical trials and client projects.
Key Responsibilities
- Lead develop and support the RA/PV team managing workloads and serving as the primary regulatory and safety contact for clients.
- Oversee clinical trial submissions and communications with Regulatory Authorities and Ethics Committees and provide regulatory sign-off on key study documents.
- Manage safety reporting including SUSARs ICSRs via EudraVigilance PSURs and ASRs as well as signal detection safety databases and Safety Management Plans.
- Act as the EU or Local QPPV or Deputy where required including oversight of the PSMF and RMP.
- Ensure GVP compliance and inspection readiness while supporting business development and continuous process improvement.
Requirements
- Degree in Pharmacy Medicine Life Sciences or a related field.
- Strong knowledge of ICH-GCP the EU CTR FDA regulations and GVP.
- Hands-on experience with regulatory submissions and pharmacovigilance including EudraVigilance and MedDRA coding.
- Experience with PSMFs and RMPs is an advantage.
- Proven experience leading teams in a regulated environment.
- Analytical client-focused approach with excellent communication skills.
- Fluency in English.
