Regulatory Affairs & Pharmacovigilance Manager

ASTRUM; Matosinhos; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Astrum CRO is seeking a Regulatory Affairs & Pharmacovigilance Manager to lead our RA/PV team, ensuring regulatory compliance and patient-safety across clinical trials and client projects.

You will oversee submissions, safety reporting, and QPPV oversight, driving continuous process improvements in a regulated environment.

Competenze

• Degree in Pharmacy, Medicine, Life Sciences, or 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 leading teams in a regulated environment.
• Analytical, client-focused approach with excellent communication skills.

Mansioni

• Lead and develop the RA/PV team and serve as primary regulatory contact for clients.
• Oversee clinical trial submissions and communications with Regulatory Authorities and Ethics Committees.
• Provide regulatory sign-off on key study documents.
• Manage safety reporting including SUSARs, ICsRs via EudraVigilance, PSURs, and RMPs.
• Ensure GVP compliance and inspection readiness while supporting business development.

Conoscenze

Regulatory affairs knowledge

GVP knowledge

ICH-GCP familiarity

MedDRA coding

Regulatory submissions

Formazione

Degree in Pharmacy/Medicine/Life Sciences

Descrizione del lavoro

• 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.