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    Pv Associate - Eug Operations

    Dr.Reddy's
    4-5 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 leading multinational pharmaceutical company dedicated to accelerating access to affordable and innovative medicines globally. Established in 1984, the company has grown into a global force with operations in 66 countries, employing over 24,000 people. Dr. Reddy’s stands for access, affordability, and innovation underpinned by a commitment to sustainability. By 2030, the company aims to reach over 1.5 billion patients worldwide. The company fosters an inclusive, diverse workforce, operating free from discrimination with a focus on innovation, transparency, and integrity.

    Job Title: Pharmacovigilance Specialist

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

    Job Description

    Dr. Reddy's Laboratories is seeking immediate joiners for the Pharmacovigilance Specialist role. The role involves supporting pharmacovigilance activities in the European region, working closely with internal and external stakeholders to ensure compliance with pharmacovigilance requirements.

    Key Responsibilities

    1. Master Product List Maintenance:

      • Maintain the master product list for Europe and its reference product list.
      • Support in preparation and management of SOPs/WIs.

    2. Deviation & CAPA Management:

      • Draft deviations and corrective and preventive actions (CAPAs).
      • Conduct effectiveness checks for CAPAs.

    3. Support to QPPV (Qualified Person for Pharmacovigilance):

      • Assist in the implementation of new pharmacovigilance activities per updated guidelines.
      • Arrange training and calls with relevant stakeholders.

    4. PSUR Submission Support:

      • Support the submission of Periodic Safety Update Reports (PSURs).

    5. Regulatory Compliance:

      • Share the latest Marketing Authorization (MA) status, SmPC (Summary of Product Characteristics), and PIL (Patient Information Leaflet) with call centers and other EU vendors.
      • Confirm product batch numbers and manage product-related queries.

    6. Adhoc EU PV Activities:

      • Support cross-functional alignment and interact with various departments for PV-related issues.
      • Manage access to Eudravigilance and assist in regulatory processes.

    Desired Skills

    • Prior Pharmacovigilance Experience: Knowledge of PV activities, especially in the EU and UK regions.
    • Relationship Management: Experience in collaborating with internal teams and external vendors/service providers for PV activities.
    • Process Improvement: Participate in process improvement and standardization initiatives under the supervision of the UK/EU QPPV.
    • Regulatory Knowledge: Understanding of EU pharmacovigilance requirements and processes.

    Qualifications

    • Educational Qualification:
      • Required: B.Pharm/M.Pharm.
      • Experience: 4-5 years of experience in pharmacovigilance.

    Competencies

    • Teamwork & Interpersonal Skills: Ability to work collaboratively in a team and interact with diverse stakeholders.
    • Time Management & Organizational Skills: Strong ability to manage multiple tasks and prioritize effectively.
    • Computer Skills: Proficiency in MS Office (Word, Excel, PowerPoint).

    About the Department

    The Global Manufacturing Organisation (GMO) at Dr. Reddy’s focuses on precision manufacturing and innovation, delivering high-quality medicines globally. The department operates 19 state-of-the-art manufacturing plants and produces a wide range of complex APIs and finished dosage forms. The GMO team drives continuous operational excellence, productivity improvement, and digitalization to ensure the highest standards in pharmaceutical manufacturing.

    Benefits Offered

    • Learning and Development: Personalized career growth programs.
    • Comprehensive Benefits: Medical, life coverage, family support (Maternity & Paternity benefits), and relocation support.
    • Work Environment: A dynamic, team-oriented, and empathetic workplace that encourages shared success.

    Why Join Dr. Reddy’s?

    At Dr. Reddy’s, you will join a purpose-driven company where Good Health Can’t Wait. You will be part of an innovative team committed to delivering quality healthcare solutions to patients across the world. The company values diversity and fosters a work environment that nurtures both individual talent and collaborative success.

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

    Let me know if you need further adjustments or specific changes to the job description!

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