Senior Post-Market Pharmacovigilance Specialist (Remote)

About the role

MMS is an award-winning, data-focused clinical research organization (CRO) supporting the pharmaceutical, biotech, and medical device industries with a proven scientific approach to complex trial data and regulatory submission challenges. As a Great Place to Work® Certified organization, we offer a collaborative and inclusive environment where your contributions truly matter.

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
• Apply expertise in ICH E2A, E2B(R3), and E2D guidelines
• Maintain pharmacovigilance quality systems and an extensive understanding of regulations and guidance related to drug safety, PV, case processing, narrative, and/or safety writing
• Understand clinical trial processes and serve as an independent project lead and subject matter expert
• Provide strategic narrative development internally and externally, including direct negotiation with clients
• Process cases independently, lead creation/updates of high-quality deliverables, and mentor others
• Work within a safety database, interact directly with clients, and demonstrate expert knowledge of coding with MedDRA and WHO drug dictionary
• Understand the impact of updates in related deliverables and manage projects from start to finish in compliance with processes
• Identify efficiencies within department processes and lead client meetings/CRMs for effective resolutions

Requirements

• College graduate in a scientific, medical, clinical discipline, or related field; master’s, PharmD, or PhD preferred
• Minimum of 5 years’ experience in drug safety, pharmacovigilance, or a similar field
• Expert knowledge of scientific principles and concepts, with expertise in using drug safety databases
• Reputation as an emerging leader in the field with sustained performance and accomplishment
• Proficiency with MS Office applications; hands-on experience with clinical trial and pharmaceutical development preferred
• Excellent problem-solving, organizational, and communication skills
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements