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    Pv Specialist - Eug Operations

    Dr.Reddy's
    10-12 years
    Not Disclosed
    Hyderabad
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm 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

    Company Name: Dr. Reddy’s Laboratories Ltd.
    Location: Global Locations
    Date: Immediate

    Company Overview

    Dr. Reddy’s Laboratories Ltd. is a global leader in the pharmaceutical industry, working with a collective purpose to accelerate access to affordable and innovative medicines. With over 24,000 employees in 66 countries, Dr. Reddy’s focuses on access, affordability, and innovation while maintaining deep scientific expertise, progressive practices, and robust governance. The company aims to reach over 1.5 billion patients worldwide by 2030 and integrates sustainability into its strategy, prioritizing people, the planet, and its purpose.

    Job Title: Pharmacovigilance Specialist

    Location: Europe (Remote/Hybrid)
    Department: Global Manufacturing Organisation (GMO)

    Job Description

    Dr. Reddy's Laboratories is hiring immediate joiners for the Pharmacovigilance Specialist role. This position involves supporting European pharmacovigilance (PV) activities and ensuring compliance with regulatory standards in close collaboration with cross-functional teams.

    Key Responsibilities

    1. Management of Risk Management Plans (RMPs):

      • Manage EU and UK RMPs under the supervision of the EU/UK QPPV.
      • Handle RMP queries and manage CMDh intimation of risks.
      • Support post-authorization updates of RMPs and track variations with Regulatory Affairs.

    2. PSUR and ACOs Management:

      • Collect and perform quality control (QC) on data for Periodic Safety Update Reports (PSURs) and Aggregate Reports (ACOs).

    3. Tracking and Documentation:

      • Maintain activity tracking spreadsheets to ensure all tasks and projects are tracked efficiently.

    4. Eudravigilance Database Management:

      • Handle Eudravigilance database tasks and conduct signal detection.

    5. Regulatory Intelligence:

      • Monitor and track PSUSAs and integrate relevant findings into the next PSUR submission.

    6. Deviation & CAPA Management:

      • Raise deviations related to PV processes and participate in CAPA development and follow-through.

    7. Audit and Inspection Support:

      • Provide support for pharmacovigilance audits and inspections, including prior experience with such activities.

    Desired Skills

    • Pharmacovigilance Experience: Experience in EU PV activities and familiarity with regulations related to Risk Management Plans (RMPs), PSURs, and Aggregate Reports.
    • Eudravigilance Knowledge: Understanding of Eudravigilance database handling and signal detection.
    • Regulatory Knowledge: Knowledge of EU/UK PV regulations and post-authorization update procedures.
    • Relationship Management: Effective interaction with EU/UK PV teams, global PV teams, and external vendors/service providers.
    • Process Improvement: Participation in process improvement and standardization initiatives under the EU/UK QPPV’s guidance.

    Qualifications

    • Educational Qualification:
      • Required: B.Pharm/M.Pharm
      • Experience: 10-12 years of experience in pharmacovigilance, including EU PV activities.

    Competencies

    • Time Management & Organizational Skills: Strong organizational skills to coordinate safety information and track multiple tasks.
    • Teamwork & Interpersonal Skills: Ability to collaborate effectively with internal and external teams.
    • Technical Skills: Proficiency in MS Office (Word, Excel, PowerPoint) and knowledge of pharmacovigilance databases.

    About the Department

    The Global Manufacturing Organisation (GMO) at Dr. Reddy’s focuses on precision manufacturing and innovation, delivering quality medicines across the globe. The department operates 19 advanced manufacturing facilities and produces complex APIs and finished dosage forms across key therapy areas. Dr. Reddy's aims to be the most efficient pharma operation globally, meeting business imperatives and ambitious environmental, social, and governance (ESG) goals.

    Benefits Offered

    • Career Development: Personalized learning programs for career growth and professional development.
    • Comprehensive Benefits: Medical, life coverage, relocation support, and family support (Maternity & Paternity benefits).
    • Work Environment: A collaborative, team-oriented culture that values innovation, diversity, and shared success.

    Why Join Dr. Reddy’s?

    Dr. Reddy’s fosters an empowered and inclusive work environment where individuals can contribute to global healthcare solutions. The company’s guiding principle of "Good Health Can’t Wait" reflects its commitment to delivering quality medicines and improving patient lives. Joining Dr. Reddy’s means becoming part of a purpose-driven company that values integrity, diversity, and a culture of collaboration.

    For more details and to apply, visit: Dr. Reddy's Careers.

    Let me know if you need further changes or details added!

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