Lead Pharmacovigilance Scientist - Safety Strategy & Signals

BioSpace; King of Prussia (PA); On-site; USD 90,000 - 150,000; Full time

Job summary

CSL Behring is seeking a Pharmacovigilance Scientist to lead safety reviews and signal detection across the product lifecycle. You will collaborate with the Global Safety Lead, review literature for safety insights, and contribute to periodic safety reports.

Responsibilities include supporting development teams with PV expertise, mentoring junior members, and coordinating with Safety Management Teams. A relevant degree and 3+ years PV experience are required.

Qualifications

• Bachelor’s or equivalent degree in pharmaceutical, nursing, biological or sciences; degree in Medicine and Pharmacy preferred.
• 3+ years’ experience as a Pharmacovigilance scientist or equivalent.
• Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines, and standards.

Responsibilities

• Lead safety review process and evaluation of safety data across product lifecycle with GSL.
• Perform end-to-end signal detection and analysis on safety data from various sources; present summaries clearly.
• Review literature for safety information for analyses or ASRs; contribute to safety reports.
• Provide input to ASRs (PSURs, DSURs, PADERs, Risk Management Plans).
• Organize insights for cross-functional Safety Management Teams (SMTs).
• Support product development teams with PV expertise on clinical data.
• Develop response strategies for safety questions from internal/external sources.
• Mentor junior PVS members; assist with onboarding and day-to-day tasks.
• Other activities: case adjudication, review of key clinical documents, SOP updates, SME support.

Skills

Pharmacovigilance

English fluency

Problem solving

Team collaboration

Time management

Data analysis

MS Excel

Education

Bachelor’s degree in pharmaceutical/biological sciences

Job description

CSL Behring is seeking a Pharmacovigilance Scientist to lead safety reviews and signal detection across the product lifecycle. You will collaborate with the Global Safety Lead, review literature for safety insights, and contribute to periodic safety reports.

Responsibilities include supporting development teams with PV expertise, mentoring junior members, and coordinating with Safety Management Teams. A relevant degree and 3+ years PV experience are required.