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    Pharmacovigilance Executive

    Piramal Pharma
    1-3 years
    Not Disclosed
    Mumbai Pune
    10 March 28, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Business: Piramal Critical Care 
    Department: Pharmacovigilance
    Location: Kurla, Mumbai
    Travel: Low
     

    Job Overview:

    The Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines
     

    Key Stakeholders: Internal
    Quality, Sales, Supply Chain, and Regulatory Affairs teams   

     
    Key Stakeholders: External 
    Vendors and auditors
     
    Reporting Structure:
    This role reports to the Manager - Pharmacovigilance
     
    Experience:
    Overall, 2-3 years of experience in Pharmacovigilance with at-least 1 year of relevant work experience in ICSR processing, Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc
     
    Competencies:
    •Good communication and interpersonal skills, both written and verbal
    •Ability to manage multiple concurrent tasks
    •Proven ability to meet strict deadlines
    •Ability to work independently and in a team environment
    •Competent in use of desktop applications: Microsoft word, excel and PowerPoint
     
    Key Role and Responsibilities:
    • End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and
    • submission to applicable regulatory authorities within stipulated timelines.
    • Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of  ICSRs.
    • Enter and/ or submit cases to applicable regulatory authority safety databases.
    • Perform and monitor literature for company molecules.
    • Maintain and update safety logs and safety files.
    • Prepare and share compliance data with QPPV.
    • Provide data for compliance representation/monthly information system.
    • Assist in handling of product complaints and reconciliation.
    • Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities.
    • Prepare for internal or external audits and inspections.
    • Preparation/Drafting of aggregate reports (PADER and PSURs).
    • Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.
     

    QUALIFICATIONS

    B Pharm/M Pharm

     

    ABOUT US

    In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
    Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
     
    Equal employment opportunity
    Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
     
    We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

    ABOUT THE TEAM

    Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.

    PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.

    Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.

    Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.

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