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    Pv Physician-Medical Assessment

    Dr.Reddy's
    5+ years
    Not Disclosed
    Hyderabad
    10 Dec. 25, 2024
    Job Description
    Job Type: Full Time Education: MBBS/MD 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: PV Physician - Medical Assessment

    Location: Hyderabad, India

    Company Overview:

    Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with a vision to accelerate access to affordable and innovative medicines. We are committed to impacting global healthcare through precision manufacturing and innovation. With a global presence in over 66 countries and a team of over 24,000 employees, our mission is rooted in a belief that Good Health Can’t Wait.

    We aim to reach over 1.5 billion patients globally by 2030, with sustainability and innovation at the core of our strategy.

    Job Summary:

    The PV Physician is responsible for overseeing and providing medical input to benefit-risk assessment activities. The role includes conducting signal detection and evaluation, reviewing and preparing aggregate reports, managing risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS), responding to regulatory queries, and supporting product labeling and clinical activities. This role involves collaboration across multiple departments including Clinical, Regulatory Affairs, Medical Affairs, and Commercial teams.

    Main Responsibilities:

    1. Medical Review & Assessment:

      • Oversee the medical assessment of individual case safety reports, ensuring quality control of vendor-submitted reports.
      • Provide medical input to aggregate reports (e.g., PSUR, PBRER, DSUR, PADER) and ensure timely preparation and submission.
      • Conduct peer quality reviews and support signal detection and validation efforts for assigned products.

    2. Risk Management & Safety Evaluation:

      • Contribute to the development and review of RMPs, REMS, and other risk minimization strategies.
      • Support the design and implementation of additional risk mitigation measures in collaboration with other teams.
      • Provide medical input to Health Hazard Evaluations and other ad hoc safety reports.

    3. Clinical & Regulatory Activities:

      • Provide safety input to clinical study protocols, study reports, CRF, and statistical analysis plans (SAP).
      • Review product labels and patient information leaflets to ensure accurate safety information.
      • Manage responses to regulatory authority queries related to pharmacovigilance.

    4. Cross-Functional Collaboration:

      • Work with PV Scientists and other internal teams to ensure regulatory compliance in aggregate safety reports and benefit-risk evaluations.
      • Support regulatory audits and inspections by ensuring all relevant documentation is in compliance with the latest regulations.
      • Provide medical and safety input to commercial, marketing, and medical affairs activities as needed.

    5. Training & Process Improvement:

      • Participate in process improvement initiatives and contribute to the development of department SOPs.
      • Provide training to new PV team members and non-PV staff on product-specific safety information.
      • Act as a subject matter expert during audits and inspections.

    Qualifications:

    • Education:

      • MBBS, preferably with an MD (Medical Doctorate).

    • Experience:

      • Minimum of 5 years of relevant pharmacovigilance experience after MBBS, ideally within the pharmaceutical industry.
      • Strong understanding of FDA, EU, and local pharmacovigilance regulations.

    • Skills:

      • Strong data analysis and report writing skills.
      • Excellent teamwork and interpersonal skills, with the ability to collaborate across various departments.
      • Good problem-solving, decision-making, and communication skills.

    Desired Competencies:

    • Familiarity with global pharmacovigilance systems, safety databases, and tools.
    • Experience in signal management and benefit-risk assessment.
    • Knowledge of clinical study protocols, safety evaluations, and regulatory requirements.

    Benefits Offered:

    • Learning & Development: Personalized learning programs to catalyze your career growth.
    • Health & Wellness: Comprehensive medical coverage for you and your family.
    • Work-Life Balance: Family support, including maternity/paternity benefits.
    • Career Progression: Opportunities to grow within an inclusive, dynamic, and diverse team.

    About the Department:

    The Global Manufacturing Organisation (GMO) at Dr. Reddy’s is committed to operational excellence and innovation. With state-of-the-art facilities in Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, we aim to be the most efficient pharmaceutical operations globally. Our facilities are recognized by the World Economic Forum as part of the Global Lighthouse Network for their commitment to digitalization and operational excellence.

    Dr. Reddy’s Laboratories is an equal opportunity employer, valuing diversity and merit. If you are ready to make a meaningful impact on global healthcare, apply today!

    For more information, visit our career page: Dr. Reddy’s Careers

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