Associate Manager Pharmacovigilance - Post-Marketing Case Processing

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 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. 

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 7 years’ experience in drug safety, pharmacovigilance, or similar field required.
• Expert knowledge of scientific principles and concepts. 
• Expertise in using drug safety databases.
• Own and drive end-to-end process development, implementation and continuous improvement
• 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.