Regulatory Affairs & Pharmacovigilance Manager
Company: ASTRUM
- Location: Matosinhos, Portugal
- Work mode: Hybrid
- Posted: 4 days ago
- Offer language: English
Job description
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.
