Novotech Drug Safety Associate Job Opening - Apply Online

Novotech Drug Safety Associate Job Opening – Apply Online

Novotech announces job opening for Pharma candidates Drug Safety Associate job opening 2020. Pharma job opening 2020, Pharmacist jobs, B Pharma job opening 2020. Safety Associate job opening 2020. Check out all the details on the same below:

Novotech is internationally recognised as the leading independent and full-service contract research organisation (CRO) in the Asia Pacific region. We provide a wide range of clinical development services across all research phases and therapeutic areas and have been instrumental in the success of hundreds of Phase I – IV clinical trials throughout the Asia Pacific.

Job Title: Drug Safety Associate

Location: Medical · Bangalore, Karnataka

Required Qualification(s):

  • Registered pharmacist or with health/biomedical degree or other related scientific degrees/qualification is required.
  • A minimum of 2 years of safety-related experience in a pharmaceutical company/CRO environment is required.
  • Knowledge and experience in international drug safety-regulatory reporting obligations and compliance, coding applications, case processing, safety processes and tools is preferred.
  • Good knowledge of medical terminology, ability to write clear, concise, unambiguous medical text is required.
  • Ability to acquire knowledge in different disease and therapeutic areas, fluency in English, ability to evaluate data and draw conclusions independently, ability to follow guidelines and procedural documents (experience of working with SOPs) is preferred
  • Computer proficiency and ability to work in specific safety databases (e.g. Argus) is essential.

Opportunities and Benefits:

To deliver clinical trial and research excellence for our clients, our people are ‘best in class’. At Novotech, we seek and nurture people with exceptional talent. We are committed to providing our people with regular internal and external training, a competitive bonus structure and a supportive work environment. We are also focused on providing our people with a wide variety of career growth and development opportunities. For more information about where your next career step at Novotech might take you, visit http://novotech-cro.com/novotech-careers.

About The Position

Due to continued growth, we are looking for a talented Drug Safety Associate to join the Medical team based in our growing Bangalore office.

You will be responsible for complete and accurate case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations.

Core Responsibilities:

  • Configuring of applicable safety database with study-specific information
    Preparing study-specific safety management plan and related tools per client requirements, SOP and guidelines
  • Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness, triage of incoming cases to prioritise for daily workflow management, completion of narrative, manual coding, approval and reconciliation of safety data
  • Liaison with medical monitors/drug safety physicians, clients and study teams as appropriate to clarify appropriate information required for case processing
  • Prioritisation of data entry activities for cases by reference to the date of receipt in accordance with SOPs and guidelines
  • Processing adverse event reports and maintaining safety database and tracking systems and preparing reports for regulatory authorities as required

Apply Online

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