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    Assistant General Manager

    Lambda Therapeutic Research
    10+ years
    Not Disclosed
    Ahmedabad
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: MBBS/MD/BHMS/BAMS/BDS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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: Assistant General Manager
    Company: Lambda Therapeutic Research Ltd.
    Location: Ahmedabad, India
    Date: December 28, 2024

    Job Description

    Lambda Therapeutic Research Ltd. is seeking an Assistant General Manager to oversee the pharmacovigilance (PV) and medical review operations within the organization. This senior role involves supporting medical leadership, managing teams, reviewing safety profiles, and ensuring compliance with global pharmacovigilance standards. The Assistant General Manager will contribute to the development and implementation of Standard Operating Procedures (SOPs), manage audit processes, and provide leadership for various PV teams.

    Key Responsibilities

    1. Audit and Compliance:

      • Collaborate with global/local Quality Assurance (QA) and Pharmacovigilance (PV) teams to assist with audit planning.
      • Review audit findings and identify areas for improvement, developing corrective actions in coordination with QA staff.
      • Ensure compliance with pharmacovigilance practices and regulatory requirements.

    2. Medical Leadership in Pharmacovigilance:

      • Provide leadership and support for the assessment of all pharmacovigilance activities.
      • Assist in the development of SOPs and working instructions, ensuring clear procedures are in place for the pharmacovigilance system.
      • Oversee the establishment and maintenance of the pharmacovigilance system in compliance with regulatory guidelines.

    3. Team Management:

      • Act as the line manager for the group leaders of medical review, signal management, and aggregate medical review teams.
      • Ensure compliance with ICSR medical reviews, signal reports, and adherence to client and regulatory requirements.

    4. Regulatory and Risk Management:

      • Provide input into Safety Data Exchange Agreements (SDEA), Pharmacovigilance Master Files (PSMF), and Risk Management Plans (RMPs).
      • Review clinical trial safety management plans, adverse event reports, and clinical expert statements per client requirements.
      • Manage regulatory authority inspections and provide input to responses to inquiries related to safety issues.

    5. Medical Review and Signal Detection:

      • Lead the medical review of aggregate reports such as PADER, PSUR, and ACOS.
      • Assess adverse events, provide causality determinations, and manage the follow-up of adverse events.
      • Perform signal detection for clients' medicinal products and assess the benefit-risk balance.

    6. Cross-Functional Collaboration and SOPs:

      • Contribute to the enhancement of pharmacovigilance processes.
      • Develop strategies for integrating cross-functional team members and group leads.
      • Review SOPs, WIs, templates, and training documents.

    7. Quality Control and Compliance:

      • Ensure timely reporting of PSUR and RMP to regulatory authorities.
      • Manage third-party commercial agreements related to pharmacovigilance reporting.

    8. Training and Development:

      • Provide medical inputs and training to team members.
      • Identify and address potential adverse events from product quality complaints.

    Key Deliverables

    • Compliance and Quality Assurance: Ensure adherence to pharmacovigilance regulations and quality standards.
    • Audit and Corrective Action Management: Efficient handling of audits and implementation of corrective actions.
    • Team Leadership and Performance: Lead medical review and signal management teams to ensure high-quality performance.
    • Regulatory Submissions: Timely preparation and submission of required safety reports (PSUR, RMP).
    • Medical Review and Signal Detection: Provide high-level oversight of medical assessments, including risk management and signal detection.

    Experience

    • 10+ years of experience in Medical Review and Signal Detection in Pharmacovigilance.
    • 5+ years of experience in team handling and leadership.

    Educational Qualification

    • Required: MBBS/MD/BHMS/BAMS/BDS or similar medical degree with relevant experience in pharmacovigilance.

    Competencies

    • Accountability: Strong ownership of responsibilities and outcomes.
    • Communication: Excellent communication skills, both verbal and written.
    • Work Ethic: Diligent and committed to high-quality work and ethical practices.
    • Initiative: Proactive in identifying and solving issues.
    • Leadership: Strong team management and leadership skills.
    • Technical Knowledge: Deep understanding of pharmacovigilance practices, regulatory compliance, and clinical safety.
    • Interpersonal Skills: Ability to work effectively in cross-functional teams and with regulatory bodies.
    • Flexibility/Planning & Organizing: Strong organizational skills with the ability to adapt to changing priorities.

    How to Apply

    Interested candidates are encouraged to apply via Lambda Therapeutic Research Ltd.'s official careers portal.

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