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Job description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn.
Please Note: The final title for this position will be determined based on the successful candidate's experience, background, and qualifications. The final scope of responsibilities and job description will be confirmed with candidates progressing to the final stage of the interview process.
Roles and Responsibilities
Lead and oversee global post-marketing case processing activities from intake through reporting and case closure
Develop and maintain pharmacovigilance workflows, procedures, and work instructions as related to post marketing case processing
Ensure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPs
Proficient in ICH E2A, E2B(R3), and E2D guidelines
Proficient in Pharmacovigilance quality systems
Maintains an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing. Understands clinical trial processes
Independent Project lead, SME; provides strategic narrative development internally and externally, directly negotiates with client
Process cases independently, understands steps involved with case processing. Leads creation/updates of high-quality deliverables
Extensive experience working within a safety database and directly interacts with clients. Expert knowledge of coding with MedDRA and WHO drug dictionary
Proficient in understanding impact of updates in related deliverables
Independently managing/leading client meetings and CRMs for effective resolutions; provides mentorship to others
Proficient with managing a project from start to finish and compliant with process; provides mentorship to others; identifies efficiencies within department processes
Requirements
College graduate in scientific, medical, clinical discipline or related field, or related experience, masters, PharmD, or PhD preferred
Minimum of 5 years’ experience in drug safety, pharmacovigilance, or similar field required
Expert knowledge of scientific principles and concepts.
Expertise in using drug safety databases
Reputation as emerging leader in field with sustained performance and accomplishment
Proficiency with MS Office applications.
Hands-on experience with clinical trial and pharmaceutical development preferred.
Good communication skills and willingness to work with others to clearly understand needs and solve problems.
Excellent problem-solving skills.
Good organizational and communication skills.
Familiarity with current ISO 9001 and ISO 27001 standards preferred.
Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
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Worksite address
chicago, IL, 60290, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.