Safety Surveillance Associate I

0 -1 yrs. in PV / 1-2 yrs. in clinical practice years

3 LPA to 5 LPA

Bangalore

25 July 11, 2024

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Surveillance Associate I

Job Description

Location:
Bangalore, India

Job Category:
Regulatory Affairs & Safety Pharmacovigilance

Department:
Global Safety - Global Business Services (GS-GBS)

Overview: Do you thrive in a dynamic environment where close collaboration with key stakeholders and strategic alignment are essential? Do you have a can-do attitude with a focus on continuous improvement? If so, this position may be right for you. Apply now and join a growing team working in an international environment.

The Position: As a Safety Surveillance Adviser, you will establish the product safety profile during development and maintain the labeling for marketed products. You will perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases, based on safety information from worldwide sources. You will also communicate drug safety issues internally and to health authorities as required. Key responsibilities include:

Acting as the owner of the safety sections of the labeling for the evolving Company Core Data Sheet (CCDS) for development products.
Maintaining labeling for marketed products and participating as a labeling change request (LCR) reviewer.
Preparing relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs).
Providing safety input to Product Development Plans (PDP), Trial Outlines, Protocols, Clinical Trial Reports, Investigator’s Brochures (IB), integrated safety summaries, abstracts, and planned publications.
Proactively communicating safety issues through participation in project/trial groups/teams and conducting Investigator training.
Responding to inquiries from Health Authorities (HAs) and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/Informed Consent (ICs).
Establishing and ensuring deliverables to/from Data Monitoring Committees (DMCs).

Qualifications:

Master's in Medicine/MD post-MBBS graduate is preferred.
Relevant experience in Signal Management, Aggregate Management, and Individual Case Safety Reports (ICSR).
Proficient in Microsoft Office (Outlook, Word, Excel, and PowerPoint).
Fluent in written and spoken English.
Analytical mindset with a professional authority.
Quality-oriented, well-organized, and striving for excellence.
Proactive planner to meet agreed deliverables.
Strong communicator (verbally and in writing).
Curious and constantly looking for improvement opportunities.
Team player with a high degree of flexibility and service-mindedness.
Cross-cultural awareness.
Ability and willingness to quickly adjust to changes in a continuously developing environment.

About the Department:

Global Safety - Global Business Services (GS-GBS) was established in 2010 as a hub for safety case processing. At GS-GBS, we handle case processing from various sources, including spontaneous, literature, solicited, and clinical trials. Our activities include safety report submission, training, Learn It administration, quality control of Individual Case Safety Reports (ICSR), Argus configuration and maintenance, information technology quality assurance, signal detection activities, risk mitigation activities, training coordination, and literature surveillance activities, including medical literature monitoring.

Working at Novo Nordisk:

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are expanding our commitment, impacting more than 40 million patient lives daily. Our success relies on the joint potential and collaboration of our more than 63,000 employees worldwide. We value the unique skills and perspectives our employees bring and work continuously to bring out the best in them. Join us! Together, we go further. Together, we’re life-changing.

Contact:

To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).

Deadline:
22nd July 2024

Commitment to Diversity and Inclusion:

We commit to an inclusive recruitment process and equality of opportunity for all job applicants. At Novo Nordisk, we recognize the need to aspire to be the best company for the world. This is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are committed to creating an inclusive culture that celebrates diversity. Together, we’re life-changing.

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Safety Surveillance Associate I

Job Description

Job Title: Safety Surveillance Associate I

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