About The Position
The Senior Pharmacovigilance Scientist leads safety review and evaluation throughout the product lifecycle, partnering with the Global Safety Lead and using quantitative and qualitative approaches. The role conducts end-to-end signal detection and analysis across safety data from multiple sources, reviews scientific and medical literature for safety information, and contributes strategic input to aggregate safety reports, including Periodic Safety Update Reports, Development Safety Update Reports, PADERs, and Risk Management Plans. The position provides insights to internal cross-functional Safety Management Teams and pharmacovigilance expertise to product development teams. It develops response strategies and conducts analyses for safety questions from internal stakeholders and external regulators. The role also mentors junior pharmacovigilance staff and may support case adjudication, review of clinical documents, SOP updates, and other dedicated pharmacovigilance activities. CSL Behring is a global biotherapeutics company focused on therapies in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas. Its scientific platforms include plasma fractionation, recombinant protein technology, and cell and gene therapy. The posting highlights CSL’s commitment to inclusion and belonging and identifies it as an Equal Opportunity Employer.
Requirements
- Bachelor’s degree or equivalent in pharmaceutical, nursing, biological, or other sciences.
- At least 3 years of experience as a Pharmacovigilance Scientist or in an equivalent position in a closely related discipline.
- Understanding of pharmacovigilance and global clinical safety methodology, regulations, guidelines, and standards.
- Ability to provide solutions to issues or challenges that arise during a project.
- Computer proficiency in basic database entry and graphics presentations, such as Microsoft Excel or equivalent.
- Excellent written and verbal communication skills in English, including the ability to evaluate, interpret, and synthesize scientific data.
- Self-motivated, with the ability to prioritize and plan effectively.
- Ability to work independently and as a team player in a cross-functional environment.
Nice To Haves
- Degree in Medicine or Pharmacy.
- Knowledge and experience in safety monitoring and signal detection.
- Understanding of ICH GCP and drug development.
Responsibilities
- Lead safety review and evaluation of safety data throughout the product lifecycle using quantitative and qualitative approaches, in partnership with the Global Safety Lead.
- Perform end-to-end signal detection and analysis on safety data sets from various sources and present meaningful summaries.
- Review scientific and medical literature for important safety information for use in analyses and aggregate safety reports.
- Provide strategic input and contributions to aggregate safety reports, including Periodic Safety Update Reports, Development Safety Update Reports, PADERs, and Risk Management Plans.
- Organize and provide key insights to internal cross-functional Safety Management Teams.
- Support product development teams, including Study Execution Teams and Clinical Development Teams, with pharmacovigilance expertise relating to clinical data.
- Develop response strategies and perform analyses for safety-related questions from internal sources and external regulatory requests.
- Mentor junior members of the Pharmacovigilance and Safety community, including onboarding support and advice on day-to-day tasks.
- Perform other activities as required, including case adjudication, review of key clinical documents such as Investigator’s Brochures and Clinical Study Reports, SOP updates, and subject matter expert support for dedicated pharmacovigilance activities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
