Job for Senior Associate in Quality Control at Novo Nordisk

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).

Post : Senior Associate Quality Control

Job Description:
KEY RESPONSIBILITIES
To perform quality control (QC) of all types of cases as per standard procedure based on relevant experience with Individual Case Safety Report (ICSR) processing
To ensure optimal training of employees in Global Safety (GS) concerning the QC process and generic case processing trainingTo identify training needs in case handling departments in GS, GS GSC and online affiliates based on QC results

TASKS
Actively participate in all relevant QC meetings and ensure that QC results are analysed and QC reports are performed timely on a monthly basis
Ensure proper feedback on all types of cases to our colleagues in India, DK and Argus Online affiliates
Responsible for providing relevant QC documents to ManagementAssist with projects as needed
Support with training of new employees in Safety Operations, GS GSC and GS as well as re- training related to own responsibilities
Support with training related to own responsibilities
Actively participate in inspections and audits and take relevant action

Quality related activities:
Update SOPs related to own job activities as applicable
Line-activities according to Quality Activity Plans (QAPs)
Prepare non-conformity reports when appropriate
Ensure that all tasks are performed in compliance with GxP

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Candidate Profile
Graduation and/or post-graduation in life sciences.
Preferably 3 years and above experience in PV.
Good knowledge of medicinal terminology and clinical pharmacology
Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety
A good knowledge of computers and databases. Fluency in English, written and spoken, is a must.
Strong ability to coordinate and prioritise tasks for ensuring department’s time and quality compliance concerning QC activities.
Good ability to guide and instruct other employees on quality procedures
Ability to efficiently collaborate and communicate with stakeholders from the global NN organisation.
Continuous contact and interaction with relevant stakeholders with very diverse professional and/or cultural background.
Understand and respect GS stakeholders expectations and concerns.
Proactively contribute to solving GS customer’s needs.

Additional Information:
Education: life sciences
Industry Type: Pharma
Functional Area: Pharmacovigilance
Location: Karnataka
Job ID: 46414BR
End Date: 10th May 2017