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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 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 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 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.