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.
About the role
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. Ensure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPs. Serve as an independent project lead and subject matter expert, providing strategic narrative development and mentorship to others.
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
- Maintain an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative, and/or safety writing
- Understand clinical trial processes
- Serve as an independent project lead and subject matter expert; provide strategic narrative development internally and externally, directly negotiate with clients
- Process cases independently, understand steps involved with case processing, and lead creation/updates of high-quality deliverables
- Extensive experience working within a safety database and direct interaction with clients
- Expert knowledge of coding with MedDRA and WHO drug dictionary
- Proficient in understanding the impact of updates in related deliverables
- Independently manage/lead client meetings and CRMs for effective resolutions; provide mentorship to others
- Proficient with managing a project from start to finish in compliance with process; identify 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 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
- 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