Here at ProClinical, we are seeking an individual to fill the newly-opened, permanent position of Senior Drug Safety and Pharmacovigilance Subject Matter Expert, based in Maryland. The ideal individual will provide oversight and guidance on matters pertaining to clinical programs that may or may not be supportive of FDA licensure/approval of medical countermeasures, and will develop and maintain a program that complies with regulatory standards. Additionally, the candidate will evaluate averse event data generated from supported clinical and preclinical programs.
- Design and provide day-to-day operational oversight and support to drug safety and pharmacovigilance system. Ensure compliance of same with relevant guidelines.
- Review and recommend release of final versions of individual case safety reports.
- Plan, design, develop and implement clinical trial protocols.
- Provide strategic and scientific input on project objectives and experimental designs to meet project needs and FDA licensure/approval requirements.
- Design and draft written safety reporting and safety management plans for clinical studies.
- Collaborate with other scientists on study design, data analysis, and study result interpretation.
- Maintain awareness of all relevant regulatory guidelines and data reporting standards.
- Disseminate relevant new regulatory guidance to relevant team members and staff.
- Provide recommendations regarding consultant’s clinical publications.
- Serve as the primary organizer, coordinator and data monitoring support individual.
- Provide expertise and support for urgent safety reviews. Prepare product safety reviews and literature reviews as required.
- Manage the safety requirements of product profiles.
- Perform proactive and ongoing risk assessments for products in development.
- Write and review annual and periodic safety reports.
- Participate in the selection and oversight of quality and budgetary aspects of external vendors providing safety and pharmacovigilance services.
- Ensure training of relevant personnel regarding drug safety reporting obligations.
- Develop and maintain relevant SOPs.
- Participate in maintaining the database of sponsored clinical trials, and generate reports for queries concerning drug safety and adverse event reporting.
- Enter data, review, and correct databases and create new data files. Assist in the development and modification of software programs to extract, tabulate, and compile safety data.
Skills And Qualifications
- 10+ years of relevant intensive experience.
- MD, PhD, RPh, PharmD, or comparable education and training.
- Knowledge and experience with all relevant safety and pharmacovigilance rules and regulations.
- Expert knowledge of MedDRA and standard safety coding conventions.
- Proven ability to analyze, interpret, discuss, and present safety information in written and oral formats.
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.