Regulatory Affairs & Pharmacovigilance Manager

Astrum CRO; Matosinhos; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

Astrum CRO is seeking a Regulatory Affairs & Pharmacovigilance Manager to lead the RA/PV team across clinical trials and client projects. You will ensure regulatory compliance and patient-safety systems, oversee submissions, safety reporting, and sign-off on key study documents.

Ideal candidates hold a degree in pharmacy, medicine, or life sciences, with strong knowledge of ICH-GCP, EU CTR, GVP, and EudraVigilance. Leadership experience in a regulated environment is essential.

Qualifications

• Degree in Pharmacy, Medicine, Life Sciences, or a related field.
• Strong knowledge of ICH-GCP, 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.

Responsibilities

• Lead and develop 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, and oversee signal detection and Safety Management Plans.
• Act as the EU or Local QPPV, or Deputy, including oversight of the PSMF and RMP.
• Ensure GVP compliance and inspection readiness while supporting business development and continuous process improvement.

Skills

Regulatory affairs

Pharmacovigilance

Team leadership

GVP compliance

ICH-GCP

EU CTR

EudraVigilance

FDA regulations

Communication skills

Education

Bachelor's degree in Pharmacy

Master’s or higher in Life Sciences (preferred)

Tools

MedDRA coding

EudraVigilance system

Job description

• Regulatory Affairs & Pharmacovigilance Manager

Regulatory Affairs & Pharmacovigilance Manager

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.