Senior Pharmacovigilance Lead — Post-Market Safety

MMS; Raleigh (NC); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

MMS is seeking a senior pharmacovigilance professional to lead global post-marketing case processing and safety deliverables from intake to closure. The role emphasizes strategic narrative development, client interactions, and mentoring junior staff within a compliant, fast-paced environment.

You will ensure adherence to GVP, FDA requirements, and ICH guidelines, while coordinating with cross-functional teams and safety databases.

Qualifications

• Minimum 5 years’ experience in drug safety, pharmacovigilance, or similar field.
• College graduate in scientific, medical, clinical discipline or related field; advanced degree preferred.
• Expert knowledge of scientific principles and drug safety concepts.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Familiarity with ISO 9001, ISO 27001, 21 CFR Part 11, FDA and GCP requirements.

Responsabilités

• 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 related to post marketing case processing.
• Ensure compliance with GVP, FDA requirements, and company SOPs.
• Proficient in ICH E2A, E2B(R3), and E2D guidelines.
• Independently manage client meetings and CRMs for effective resolutions; mentor others.
• Lead creation/updates of high-quality deliverables and supervise safety database activities.

Connaissances

Pharmacovigilance

Project leadership

Client negotiation

GVP compliance

MedDRA coding

FDA regulations

Formation

Bachelor's degree in science

PharmD or PhD (preferred)

Outils

MS Office

Description du poste

MMS is seeking a senior pharmacovigilance professional to lead global post-marketing case processing and safety deliverables from intake to closure. The role emphasizes strategic narrative development, client interactions, and mentoring junior staff within a compliant, fast-paced environment.

You will ensure adherence to GVP, FDA requirements, and ICH guidelines, while coordinating with cross-functional teams and safety databases.