Proclinical is currently recruiting for an Analytical Chemist with a pharmaceutical company located in North Chicago, IL. Responsible for the receipt, processing, triage and quality assessment of all inbound safety information including adverse events and technical complaints for our marketed products (drugs and devices). Also responsible for ensuring compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety information.
- Ability to perform all responsibilities of more junior staff, including but not limited to processing of adverse events and associated technical complaints and analysis results related to marketed products into the complaint and global safety databases, including but not limited to duplicate searches, product coding, medDRA coding, narrative generation
- Labeling assessment according to the current approved product label
- Receive inbound and make outbound calls for adverse events and technical complaints including handling of refund of replacement requests
- Manage all outbound letters and inbound letters
- Collect and document information received during outbound follow-up calls
- Generate acknowledgement and follow-up letters
- Perform triage, case classification and case assignment
- Assist with training of new hires; mentor new hires
- Perform reconciliations
- Perform quality check of adverse events and associated technical complaints including a review of the case complaint and safety descriptions for completeness, and evaluation and confirmation of case seriousness, review of coding of products, medical history, indications and adverse events, and the final quality check of all case content
- Provide ongoing feedback regarding case quality to case handlers to support their continued development and ensure excellent case quality
- Assist with workload coordination
- Build customer loyalty by providing high quality customer service
- Provide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scripts
- Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and support implementation of solutions
- Assist with department related projects
Skills and Requirements:
- Bachelor's degree required (in medical or science-related discipline)
- A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience Safety (including MedDRA coding and adverse event identification) preferred
- A minimum of 2 years of Customer Service experience preferred
- Strong knowledge of medical and pharmacovigilance terminology required
- Knowledge of NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders)
- Experience with audits/inspections preferred
- Analytical thinking skills required
- Proficiency in Windows, Microsoft Word, Excel and Outlook required
- Experience with a Call Center and Drug Safety database preferred
- Strong oral and written communication skills required
- Ability to work with sensitive or confidential information required
- Strong attention to detail required
- Ability to handle multiple priorities and demands in a fast-paced environment required
- Strong planning, organizational and time management skills required
- Ability to interact with various levels of the organization required
- Ability to form strong working relationships with stakeholders required
- Bi-lingual (Spanish-English) a plus
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 contact Mike Raletz at 267-428-7770 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.