About this role
Pharmacovigilance Lead
MMS Holdings Inc.
Roles and 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 7 years’ experience in drug safety, pharmacovigilance, or similar field required.
- Expert knowledge of scientific principles and concepts.
- Expertise in using drug safety databases.
- Own and drive end-to-end process development, implementation and continuous improvement
- 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.