Senior Manager, Post-Market Pharmacovigilance (Remote - US)

MMS Holdings Inc; Chicago (IL); Remote; USD 140,000 - 180,000; Full time

Job summary

MMS Holdings Inc is seeking a seasoned Pharmacovigilance professional to lead global post-marketing case processing from intake through reporting and closure. This role focuses on developing PV workflows, ensuring GVP and FDA compliance, and mentoring team members.

The candidate should have extensive experience with MedDRA and WHO drug dictionaries, and be capable of directing client-facing meetings while maintaining high-quality deliverables in a fast-paced CRO environment.

Qualifications

• 8+ years of experience in drug safety/pharmacovigilance or related field.
• Experience with regulatory guidelines and quality systems.

Responsibilities

• Lead global post-marketing case processing from intake to closure.
• Develop and own pharmacovigilance workflows and SOPs.
• Ensure compliance with GVP, FDA requirements, and company SOPs.
• Mentor team members and lead client meetings.
• Interact with safety databases and provide regulatory-submission support.

Skills

Post-marketing case processing

Pharmacovigilance

GVP/FDA compliance

ICH guidelines (E2A/E2B/E2D)

Safety database usage

Client meetings/leadership

Education

Master’s degree in science/medical field

PharmD or PhD preferred

Tools

MedDRA

WHO drug dictionary

Job description

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. 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 closure.
• Develop, maintain, and ownership of pharmacovigilance workflows, procedures, and work instructions as related to post marketing case processing.
• Establish quality review frameworks for case processing activities
• 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.
• Recognized asSME; provides strategic 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.
• Understand interactions between postmarket pharmacovigilance and US REMS requirements

Requirements:

• College graduate in scientific, medical, clinical discipline or related field, or related experience, masters, PharmD, or PhD preferred.
• Minimum of 8 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.