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    Deputy Manager

    Lambda Therapeutic Research
    5+ years
    Preferred by Comapny
    Ahmedabad
    10 Nov. 24, 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, 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: Deputy Manager - Pharmacovigilance

    Location: Ahmedabad, India
    Company: Lambda Therapeutic Research Ltd.

    Organisational Overview

    Lambda Therapeutic Research Ltd. is a globally recognized Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With operations spanning India, the USA, Canada, the UK, and Poland, Lambda offers end-to-end clinical research services to the pharmaceutical, biotech, and generic drug industries. Renowned for regulatory excellence and innovation, Lambda has been honored with awards such as ‘Regulatory Excellence’, ‘Industry Partner of the Year’, and ‘Best Indian CRO’, reflecting its commitment to quality and compliance in clinical research.

    Position Overview

    The Deputy Manager - Pharmacovigilance will play a pivotal role in ensuring the safety of pharmaceutical products by overseeing pharmacovigilance activities, regulatory compliance, and team management. The role requires expertise in adverse event management, regulatory submissions, and process enhancement to ensure timely and accurate reporting of safety data.

    Key Responsibilities

    Pharmacovigilance Operations

    • Provide pharmacovigilance expertise and advice to clients and colleagues.
    • Ensure all pharmacovigilance activities comply with Standard Operating Procedures (SOPs), relevant regulations, and guidelines.
    • Conduct medical assessments of adverse event (AE) reports, including causality assessment and narrative review.
    • Perform data entry and coding tasks, including MedDRA coding and listedness evaluation.
    • Lead the follow-up on adverse events and prepare regulatory authority responses.

    Regulatory Compliance

    • Stay updated on local, national, and international pharmacovigilance regulations and implement them effectively.
    • Ensure the timely submission of Individual Case Safety Reports (ICSRs) and Aggregate Reports to achieve 100% regulatory compliance.
    • Contribute to the development of SOPs and work instructions to enhance pharmacovigilance processes.

    Team Leadership & Training

    • Manage the pharmacovigilance team, ensuring proper workload distribution and task allocation.
    • Act as a line manager for medical reviewers and oversee strategic work distribution.
    • Train and mentor new team members to ensure competence before independent task allocation.
    • Deliver ongoing training sessions to the team as needed.

    Process Improvement & Support

    • Identify opportunities for continuous process improvement within pharmacovigilance activities.
    • Provide backup medical support on products/projects where required.
    • Collaborate with cross-functional teams to address any issues arising during reviews.

    Communication & Collaboration

    • Maintain professional communication with regulatory authorities, healthcare professionals, and internal stakeholders.
    • Act as a point of contact for inquiries regarding safety issues and pharmacovigilance processes.
    • Work closely with Aggregate Report/ICSR team leaders to escalate issues or tasks beyond the normal scope.

    Experience & Qualifications

    Experience

    • 5+ years of experience in pharmacovigilance, with demonstrated expertise in team management.
    • Strong background in adverse event reporting, medical assessments, and regulatory compliance.

    Educational Qualifications

    • MBBS/MD in Pharmacology or a related discipline.

    Key Competencies

    • Leadership: Proven ability to manage teams and lead projects effectively.
    • Accountability: Strong commitment to regulatory compliance and quality.
    • Technical Expertise: Deep knowledge of pharmacovigilance processes, regulations, and tools like MedDRA.
    • Communication: Excellent verbal and written communication skills.
    • Interpersonal Skills: Ability to mentor, train, and collaborate with cross-functional teams.
    • Problem-Solving: Strong analytical and troubleshooting skills.

    Why Join Lambda?

    Lambda offers an inspiring workplace culture that values excellence, innovation, and collaboration. As a Deputy Manager - Pharmacovigilance, you will have the opportunity to contribute to life-changing healthcare advancements while advancing your career in a supportive and dynamic environment.

    Be a part of Lambda Therapeutic Research Ltd. and help redefine the future of clinical research and pharmacovigilance.

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