Senior Post-Market Pharmacovigilance Specialist (Remote)

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.

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