Senior Drug Safety Specialist
Proclinical is currently recruiting for a Senior Drug Safety Specialist for a pharmaceutical company located in Waltham, MA. Successful candidate will be responsible for processing and reporting individual case safety reports (ICSRs) received from all sources for investigational and marketed products.
- Perform case processing activities including triage, data entry, adverse event extraction and ranking, selecting or verifying the appropriate coding, narrative preparation, and case submissions.
- Perform initial case assessment for seriousness and expectedness/labeling based on medical context and regulatory requirements.
- Perform initial assessment to determine if the case meets criteria for adverse event of special interest.
- Review source documents and ICSR information in order to verify accuracy, completeness and consistency. Perform Quality Control on cases processed by other team members.
- Generate follow-up requests and contact reporters as appropriate to obtain missing case information and/or additional clarifications. Ensure that all required follow-up attempts for assigned cases have been completed. Track and document all queries.
- Determine and/or confirm if the case meets expedited reporting criteria. Ensure adverse event reporting compliance with company's SOP's, SDEA timeframes, FDA, EMA, ICH and other regulatory requirements.
- Maintain working knowledge of regulatory requirements, guidance documents, SOPs, work instructions and other internal documents as related to ICSR processing and evaluations.
- Assist with AE/SAE reconciliation prior to clinical trial database closure.
- Work collaboratively with pharmacovigilance physicians on ad-hoc data reviews as needed.
- Assist with preparing and/or reviewing ICSRs or safety summaries for aggregate safety reports (DSUR, PADERs, PSURs,) as needed or requested.
- Interface with external and internal partners.
- Assists with the development and/or updates of SOPs, Work Instructions, forms, conventions or other internal documents as needed.
- Performs other duties as assigned.
Skills and Requirements:
- Pharm D, BA/BS in pharmacy, nursing, life sciences or equivalent. MA/MS or other advanced degree in life sciences is a plus.
- 3+ years' experience in pharmacovigilance/drug safety.
- Working knowledge of drug safety databases is required.
- Working knowledge of MedDRA and WhoDrug coding principles and practical applications.
- Knowledge of guidance documents and regulatory requirements as applied to clinical trial and post-marketing adverse event reporting.
- Demonstrated ability to set priorities, work independently and collaboratively.
- Demonstrated ability to apply clinical judgment and clearly communicate complex issues.
- Strong organizational skills and demonstrated ability to focus on quality with attention to details.
- Excellent written and oral communication skills.
- Proficiency in the use of Windows and MS Office applications and ability to learn new systems as needed.
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 Brendan Dunn at (+1) 646-481-1930 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.
Proclinical Staffing is an equal opportunity employer.