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Responsibilities
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.MMS is a great place to advance your career. Visit www.mmsholdings.com 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 closureDevelop and maintacedures, and work instructions as related to post marketing case processingEnsure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPsProficient in ICH E2A, E2B(R3), and E2D guidelinesProficient in Pharmacovigilance quality systemsMaintains an extensive understanding of regulations and guidance as they pertaluding case processing, narrative and/or safety writing. Understands clinical trial processesIndependent Project lead, SME; provides strategic narrative development internally and externally, directly negotiates with clientProcess cases independently, understands steps involved with case processing. Leads creation/updates of high-quality deliverablesExtensive experience working within a safety database and directly interacts with clients. Expert knowledge of coding with MedDRA and WHO drug dictionaryProficient in understanding impact of updates in related deliverablesIndependently managing/leading client meetings and CRMs for effective resolutions; provides mentorship to othersProficient with managing a project from start to finish and compliant with process; provides mentorship to others; identifies efficiencies within department processesRequirements:College graduate ical, clinical discipline or related field, or related experience, masters, PharmD, or PhD preferredMinimum of 5 years’ experience rmacovigilance, or similar field requiredExpert knowledge of scientific principles and concepts.Expertise in using drug safety databasesReputation as emerging leader in field with sustained performance and accomplishmentProficiency 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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