Senior PV Lead: Safety Reporting & Strategy

Ptc Therapeutics; Guildford; On-site; GBP 110,000 - 140,000; Full time

Job summary

PTC Therapeutics, based in the United Kingdom, seeks an Associate Director of Pharmacovigilance to lead safety activities for clinical trials and post-marketing products. You will manage PV deliverables, coordinate aggregate reports, and ensure global PV regulatory compliance.

You will partner with safety physicians, CROs, and Regulatory Affairs to meet timelines, guide PV processes, and support SRB meetings and risk management plans.

Qualifications

• BSN or Bachelor’s in Pharmacy or related life science with at least 8 years of PV experience.
• Expert knowledge of FDA/EU/ICH pharmacovigilance guidelines.
• Experience in scientific writing and project management.
• Extensive MedDRA proficiency.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead PV activities for assigned products across development and post-marketing.
• Project manage PV aggregate reports (DSUR, PBRER, topic reports).
• Collaborate with safety physician to meet regulatory reporting deadlines.
• Contribute to PV safety reports and provide training to other functions.
• Oversee the PV aggregate report review process with internal/external stakeholders.
• Collaborate with clinical teams, CROs, Regulatory Affairs to ensure timely submissions.

Skills

Pharmacovigilance

Project management

Medical writing

MedDRA

Regulatory knowledge

Communication skills

Team collaboration

Education

BSN or Bachelor’s in Pharmacy or related life science

Job description

PTC Therapeutics, based in the United Kingdom, seeks an Associate Director of Pharmacovigilance to lead safety activities for clinical trials and post-marketing products. You will manage PV deliverables, coordinate aggregate reports, and ensure global PV regulatory compliance.

You will partner with safety physicians, CROs, and Regulatory Affairs to meet timelines, guide PV processes, and support SRB meetings and risk management plans.