ProClinical is recruiting for the exciting new role of Principal Scientist of Epidemiology, based in San Francisco, CA . The ideal candidate will work closely with our client’s Pharmacovigilance Medical Directors to contribute to safety aggregate reports, signal detection and evaluation, and safety review teams and committees on a permanent basis.
- Support global implementation of risk management, including the development and revision of procedural documents.
- Provide safety and broad epidemiology expertise.
- Contribute to safety signal work-ups and preparation of relevant reporting.
- Design and oversee observational studies, if required.
- Contribute to regulatory submission documents, interactions with global regulatory agencies, and interaction with external partners.
- Develop and maintain tools for benefit risk assessment.
- Support preparation of safety-related review sections, clinical study reports, investigative materials, study tools, etc.
- Use relevant tools to aid understanding of event rates in groups.
Skills And Qualifications
- 5+ years’ experience or equivalent subject matter expertise in relevant field.
- PhD or Master’s degree in epidemiology, public health or relevant field. PharmD, MD or advanced health-related sciences education preferred.
- Drug development and post-marketed product experience preferred.
- Oncology therapeutic area experience preferred.
- Strong background in biostatistical methodology, used in drug development, analysis and reporting.
- Strong background in regulations and requirements for safety reporting.
- Leadership skills.
- Excellent communication (written and verbal) and interpersonal skills.
- Occasional business travel (up to 10%) will be required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 6465420152 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.