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    Quality & Process Specialist

    Katalyst Healthcares & Life Sciences
    5-7 years
    Not Disclosed
    Bridgewater
    10 July 19, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Entry Level Positions in Drug Safety and Pharmacovigilance and Clinical Research

    Company: Katalyst Healthcares & Life Sciences

    Location: Various locations, working with University hospitals, pharmaceutical companies, and recruiting partners

    Type: Full-time, Contract

    Company Description:

    Katalyst Healthcares & Life Sciences is hiring entry-level candidates for several positions in contract research involving clinical trials of drugs, biologics, and medical devices. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners.

    Job Description:

    Responsibilities:

    • Quality Assessment:

      • Under the supervision of the PV QTC QC/QA Head, perform quality assessments on the content of data/output and key Pharmacovigilance activities.
      • Measure compliance to process, process effectiveness, and data quality as pre-identified in the quality plan.
      • Investigate issues, identify root causes, and propose Corrective Action Plan Activities (CAPA).
      • Participate in CAPA implementation and ensure monitoring activities to measure effectiveness.

    • Continuous Improvement:

      • Participate in the GPE Quality continuous improvement and Operational excellence programs.
      • Track the added value and success of such initiatives.

    • Risk Detection:

      • Detect processes at risk requiring further quality assessments in the Pharmacovigilance network.

    • Collaboration:

      • Interact with CMQ&O auditors, GPE PV Affiliates Relations group, and other functions to provide input on audit/visit actions in affiliates PV units.
      • Collaborate with any GPE units involved in the reviewed activity and generating data/outputs to discuss findings and propose consistent corrective action plans.
      • Provide input or receive feedback on findings from the User Support group.

    Requirements:

    • Analytical Skills:

      • Strong analytical skills with the ability to ensure scientific rigor and good quality in all analyses.
      • Sound risk-based judgment in decision-making.

    • Communication Skills:

      • Excellent writing and communication skills.
      • Strong interpersonal skills to interact with individuals of various backgrounds and levels.

    • Independent Work:

      • Ability to work independently and manage multiple priorities simultaneously.
      • Ability to identify gaps in quality issues and investigate root causes.

    • Corrective Action:

      • Demonstrated ability to participate in the creation of corrective action plans and monitor their effectiveness.

    • Technical Skills:

      • Computer literacy (Microsoft Office).
      • Good understanding of Quality Management Systems and their implementation.
      • In-depth knowledge of international Pharmacovigilance requirements (US FDA, EMEA guidelines, ICH/CIOMS).
      • Experience in quality management, QA, audits, and CAPA methodology would be a plus.
      • Understanding of database organization and documentation systems would be a plus.

    Education:

    • Minimum Experience:
      • 5 to 7 years in International Pharmacovigilance activities including case processing and interaction with affiliates.
    • Certified Health Professional Degree Required:
      • Examples include Pharmacist, PharmD, or Bachelor of Nursing degree.
    • Knowledge:
      • Demonstrated understanding of Pharmacovigilance processes, PV database systems, and dictionaries.
      • Knowledge of international regulations and guidelines (ICH, CIOMS, EMEA/FDA).

    Additional Information:

    • All information will be kept confidential according to EEO guidelines.

    For more information or to apply, please visit Katalyst Healthcares & Life Sciences.

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