Associate Manager, Pharmacovigilance| Post-Marketing Case Processing

Job highlights

• provides mentorship to others. . Proficient with managing a project from start to finish and compliant with process
• Expert knowledge of coding with MedDRA and WHO drug dictionary. . Proficient in understanding impact of updates in related deliverables.
• Minimum of 7 years experience in drug safety,pharmacovigilance,or similar field required.

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.

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