Novo Nordisk – Pharmacovigilance Drug safety expert Job vacancies Bangalore

Novo Nordisk Pharmacovigilance Drug Safety Expert I Job Openings at Bangalore Location.

Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN

The position

  • As a Drug Safety Expert unit, you will be the one who set and achieve day-to-day operations with some impact on others within or outside the unit.
  • Handling of non-serious and serious adverse events. Training on the process.
  • Actively participate in audits and inspections. Ensure cross organizational communication and cooperation; and support implementation of new processes based on increased regulatory requirements and in accordance with GS’s strategic framework. SOP author.
  • Typically reports to a Head of the Project

Handling of Non-serious and Serious adverse events:

  • Perform initial evaluation of reported adverse events (serious and non-serious) from all sources.
  • Perform case entry and verification of reported non-serious and serious adverse events; enter
  • the reported information in the Novo Nordisk safety database – Argus, based on individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
  • Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).
  • Evaluate causality, seriousness, and listed ness for all cases.
  • Ensure that case narrative comprises correct and appropriate safety information.
  • Assess the need for follow up information and issue follow up requests for all cases and post
  • queries in EDC and/or to affiliate.
  • Perform weekly literature surveillance related activities.
  • Ability to work within strict timelines.

In addition:

  • Ensure that all tasks are performed in compliance in accordance with GXP requirements.
  • Maintain a network of safety contacts within Global Safety (GS) and affiliates.
  • Communicating with the SO-DK and affiliates to query and/or clarify the details related to the safety data.
  • Having extensive knowledge of Novo Nordisk global safety database (Argus) and Global Customer Complaint System (CCGloW).
  • Must be owner or involved in the creation and maintenance of standard operating procedure.
  • Global Safety processes.
  • Assist/provide response to health authority requests.
  • Support implementation of new processes and/or requirements based on increased regulatory requirements.
  • Ensure cross organizational communication and cooperation with regards to safety information

This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management, communication skills. Ensure quality of submissions by complying to procedures and systems.

Qualifications

  • Graduation and /or Post Graduation in (life Sciences)
  • 7 – 10 years of experience in a similar environment.
  • Sound knowledge of Pharmacovigilance is expected.
  • Knowledge of medical terminologies and clinical pharmacology.
  • Good understanding of the internal and external Pharmacovigilance setting and requirements.
  • Sound working knowledge of MS Windows applications including MS Office tools.
  • Solid Novo Nordisk organizational or pharmaceutical company understanding.
  • Excellent communication skills (written and oral), with English correspondence.
  • Good presentation skills
  • Solid knowledge of Novo Nordisk products, incl. mechanism of action, safety profile, patient population, etc.
  • Well versed with CAPA (Corrective and Preventive Action) process.
  • Expert in Case Management Request vertical.
  • Good knowledge of GXP requirements.
  • Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety

Deadline : 29 June 2022

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants

Novo Nordisk - Pharmacovigilance Drug safety expert Job vacancies Bangalore
Novo Nordisk – Pharmacovigilance Drug safety expert Job vacancies Bangalore

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