Senior PV Safety & Reporting Lead

PTC Therapeutics, Inc.; Dublin; Vor Ort; EUR 150.000 - 190.000; Vollzeit

Zusammenfassung

PTC Therapeutics, Inc. is seeking an Associate Director, Pharmacovigilance to lead safety activities for our clinical and post-market programs. You will manage PV deliverables, including DSURs and PBRERs, while coordinating with risk management and regulatory teams across functions.

The role requires a deep knowledge of global PV regulations, MedDRA, and strong writing and project-management skills. The successful candidate will guide safety reporting and oversee cross-functional SRB processes

Qualifikationen

• BSN or Bachelor's in Pharmacy or related life science with 8+ years PV experience.
• Expert knowledge of FDA, EU and ICH PV guidelines and regulations.
• Experience in scientific writing and PV reporting.
• Proficiency in MedDRA and PV terminology.
• Strong communication, project management and cross-functional collaboration.

Aufgaben

• Lead PV activities for assigned product(s) and therapeutic areas.
• Own PV aggregate reports (DSUR, PBRER, topic reports) and SRB participation.
• Collaborate with safety physician and stakeholders to meet regulatory deadlines.
• Contribute to PV safety reports and provide training to other functions.
• Oversee PV process improvements and ensure timely regulatory submissions.
• Coordinate with EU/local QP to maintain PV processes for development and marketed products.

Kenntnisse

Regulatory knowledge

Project management

Scientific writing

MedDRA proficiency

MS Office

Cross-functional collaboration

Analytical thinking

Time management

Effective communication

Stakeholder influence

Ausbildung

BSN or Bachelor’s in Pharmacy or related life science

Tools

eDMS software

MedDRA

Jobbeschreibung

PTC Therapeutics, Inc. is seeking an Associate Director, Pharmacovigilance to lead safety activities for our clinical and post-market programs. You will manage PV deliverables, including DSURs and PBRERs, while coordinating with risk management and regulatory teams across functions.

The role requires a deep knowledge of global PV regulations, MedDRA, and strong writing and project-management skills. The successful candidate will guide safety reporting and oversee cross-functional SRB processes