Covance

  • Senior Drug Safety Associate

    Job Location(s) IN-Bangalore | IN-Bangalore
    Job Number
    2018-16988
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Work Location: Bangalore

     

    Responsible for assisting with the smooth running of the PV&DSS Department to ensure all adverse events are processed to the required standard and submitted to the client and the regulatory agencies (if required) within the agreed upon timelines.  This post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.

     

    It is the responsibility of the post holder to provide all clients, both internal and external with the appropriate quality of service in a safe and cost –effective manner.

     

    He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.

     

    Essential Job Duties:                                                                

    • Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.
    • Assist in producing queries of safety data for clients as appropriate.
    • Assist in the generation and maintenance of the PV&DSS metrics.
    • Assist Data Management or clients on reconciliation of safety databases.
    • Provide input for monthly status reports.
    • Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
    • Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety.
    • Build and maintain good PV&DSS relationships across functional units.
    • Demonstrate role-specific Core Competencies on a consistent basis.
    • Demonstrate company Values on a consistent basis.
    • Assist in the preparation of client meetings and liaise with clients where appropriate.
    • Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
    • Any other duties as assigned by management.

    Top 3 reasons you should join us:

     

    1. Energizing purpose: Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.
    2. Exceptional people: You will join a growing team of people who have a common goal for exceptional service and quality. You will learn from the most talented minds and subject matter experts, in an agile, supportive, and caring environment.
    3. Extraordinary potential: You will work in a most stimulating and a flexible work environment that will help you thrive personally and professionally.

     

    Get to know Covance

    Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world.  Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.

     

    Over the years we have been recognised and applauded for our efforts in the creation of personalised medicines and innovative therapies to deliver on the promise of a healthier world. Some of our recent accolades:

    • LabCorp named in FORTUNE Magazine's 2018 list of ‘World’s Most Admired Companies”
    • Frost & Sullivan Best Practice Award – Asia Pacific CRO Growth Excellence Leadership Award
    • IMDiversity – Corporate Diversity Honor Roll
    • Flexjobs – Top 100 Remote Work – Company to Watch
    • Life Science Strategy Group – Rated as the CRO “Making the right moves to be successful in the future”

    To learn more about our exciting opportunities in India, visit www.Covance.com/IndiaCareers

    Education/Qualifications

    Education:

     

    Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.

    Experience

    Required:

    • High degree of accuracy with attention to detail.
    • Functions as a team player.
    • Good communication.
    • Good written and verbal communication skills.
    • Ability to work independently with moderate supervision.
    • Good keyboard skills with knowledge of MS Office and Windows application would be beneficial.

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