Drug Safety Expert I
5 days ago
Drug Safety Expert I
**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety GBS (GS - GBS).-
**The Position**
- A Drug Safety Expert will be responsible to ensure all the conventions are followed by safety case handlers and would drive quality deliverables, he or she would act as a bridge between management and case handlers and would drive all the technical aspects of the case processing, they would constantly monitor the trends on the floor and would take action of course correction wherever required. They would also be responsible for various inspections and audits related to Post marketing case management.- An expert may 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 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 listedness 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.
- Drive Inspections and Audits.
**Qualifications**
- 6+ years of relevant (PV) experience/Graduation and/or post-graduation in life sciences is required.
- Sound knowledge of Pharmacovigilance is expected.
- Knowledge of medical terminologies and clinical pharmacology.
- Good understanding of the internal and external Pharmacovigilance setting and requirements.
- 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.
- Good knowledge of GXP requirements.
- Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety.
- Experience of project management in handling PV process.
- Experience of Implementing simplification of PV process.
- Good knowledge of GVP Module-VI
- An Eye for detail and ability to find trends or issues.
**About the Department**
- Global Safety Global Business Service (GS-GBS) was set up in 2010 as one of the hubs for safety case processing. We handle case processing and medical review of Individual Case Safety Reports from different sources (spontaneous, literature, solicited and clinical trials). We are additionally engaged in safety surveillance, safety medical writing, safety report submission, training, quality control of ICSRs, Argus configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.**Working At Novo Nordisk**
- At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.**Contact**Deadline**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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