Pharmacovigilance Scientist

Pharmacovigilance Scientist

KING OF PRUSSIA, PA

02 Apr 2026 22466447 Summary

KING OF PRUSSIA, PA

Hybrid $45.34 - $53.76 per Year 0 Years Experience Any degree above a Master's - e.g. Ph.D., Ed.

D., J.D. No Commission 40.00 hours per week / Day Shift / Full-Time

Description Duties:

Support Global Safety Lead (Physicians) in the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches. Undertake signal detection activities on safety data sets from various sources, such as spontaneous adverse event listings, clinical trial datasets, reports or datasets from observational studies and present summaries of the data in a meaningful way. Review publications from the scientific and medical literature for important safety information; summarize and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, signal evaluations). Draft safety-related documents, particularly sections relating to safety risk management e.g. periodic safety update reports, development safety update reports, clinical overview addenda to support registration activities; and contributing to reviewing safety sections of other clinical or regulatory documents including Investigator's brochures and submission dossiers. Contribute to the production of, and updates to, Risk Management Plans for CSL manufactured products, including drafting of the safety sections. Support ongoing risk management activities by participation in and coordination of the operational and scientific activities associated with internal cross functional Safety Management Teams for the associated products. Participate in associated development teams, such as the Study Execution Team and the Clinical Development Team, in collaboration with the Global Safety Lead (Physicians). Support the physician in providing responses for safety-related questions from internal sources and/or external regulatory requests.

Contribute to quality improvement:

Review, prepare, and/or update local and global SOPs and working instructions as required. May work from home.

Requirements:

 PhD (or foreign equivalent) in Pharmaceutical, Nursing, Biological Sciences, Pharmacology, or Pharmaceutical Science with no experience; or Bachelor's degree (or foreign equivalent) in Pharmaceutical, Nursing, Biological Sciences, Pharmacology, or Pharmaceutical Science plus 5 years of experience in the offered position or related position.

Special Requirements:

 Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time".

Required expertise/knowledge includes:

Experience in applying understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines and standards, including signal detection and signal management process, drafting aggregate reports, risk management process and giving inputs to labeling documents, to ensure submission to regulatory bodies worldwide is done in a timely manner. Experience evaluating, interpreting and synthesizing scientific data, including safety monitoring and signal detection to ensure data for the product under development or marketed remains safe for patients. Full understanding and application of

ICH GCP, GVP

guidance and drug development principles. Experience leading teams/ project teams in a global cross-functional environment. Ability to write reports, business correspondence and procedures and read, analyze and interpret professional journals, technical procedures, and governmental regulations (21CFR part 11, Medical Device Reporting (MDR) and ICH guidelines). Experience collaborating in a matrixed team environment consisting of internal and external team members. Experience with safety databases, including Argus and Empirica. Additional Details How To Identify Potential Job Scams