Here’s a refined version of the job description for the position of Safety Surveillance Adviser I:
Position: Safety Surveillance Adviser I
Category: Regulatory Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, India
Department: Global Safety - Global Business Services (GS-GBS)
Are you motivated by challenges and dynamic environments? Do you thrive in collaborative settings where strategic alignment is key? If you have a can-do attitude and a focus on continuous improvement, we have the right opportunity for you. Join our growing team and contribute to an international environment.
As a Safety Surveillance Adviser, you will play a pivotal role in establishing and maintaining the safety profile of Novo Nordisk (NN) products during their development and throughout their lifecycle. You will be responsible for ongoing safety surveillance, coordinating with global stakeholders, and ensuring clear communication of safety information internally and with health authorities (HAs).
Safety Profiling:
Act as the owner of the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for development products. Maintain labelling for marketed products, review labelling change requests (LCRs), and provide safety input.
Safety Reporting:
Author sections of key safety reports, including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, and clinical Risk Management Plans (RMPs). Respond to inquiries from health authorities (HAs) and NN affiliates.
Safety Input to Clinical Development:
Provide safety input to Product Development Plans (PDP), trial protocols, Clinical Trial Reports, Investigator’s Brochures (IB), integrated safety summaries, abstracts, and planned publications.
Collaboration & Communication:
Participate in project and trial teams, provide proactive safety communication, conduct investigator training, and respond to safety-related inquiries from HAs and Ethics Committees (ECs).
Cross-Functional Safety Committee:
Establish, operate, and chair the cross-functional safety committee, presenting safety analysis and results for endorsement and recommendations throughout the lifecycle of the product.
Education:
Masters in Medicine or MD (post-MBBS) preferred.
Experience:
Relevant experience in Signal Management, Aggregate Management, and Individual Case Safety Reports (ICSRs).
Skills & Competencies:
Global Safety - Global Business Services (GS-GBS) has been a hub for safety case processing since 2010. We manage safety reports from various sources, including clinical trials, spontaneous reports, literature, and solicited data. Our team is also responsible for safety report submission, quality control, signal detection, risk mitigation, and training coordination.
Novo Nordisk is a global healthcare leader with a 100-year legacy in combating chronic diseases. With a strong foundation in diabetes care, we are rapidly expanding our impact, reaching millions of patients globally. As one of the most valuable companies by market cap, we value the diverse perspectives and skills of our employees. Together, we go further and drive life-changing outcomes.
Deadline for Applications: 5th January 2025
How to Apply:
Submit your application by uploading your CV and motivational letter via the Novo Nordisk online portal. Click on "Apply" and follow the instructions.
Important Notice:
Novo Nordisk has recently become aware of fraudulent job offers. Please be advised that we do not extend unsolicited employment offers or request personal information, payment for equipment, or funds during recruitment. For verification, please contact our official recruitment channels.
Commitment to Diversity & Inclusion:
We are committed to creating an inclusive work environment where all applicants are treated fairly, regardless of race, religion, gender, age, disability status, or any other characteristic. At Novo Nordisk, we embrace diverse perspectives and celebrate our employees, the patients we serve, and the communities in which we operate.
Let me know if you'd like any additional adjustments or details!
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Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Ahmedabad | Baroda | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
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Farmington | Santa Fe | Tucumcari |New York :
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Netherlands |Noord Holland :
Haarlem |South Holland :
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Vienna |Antwerp :
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Sofia |Canada :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
Cairo |South Yorkshire :
Sheffield |United Kingdom :
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Jakarta |Israel :
Be'Er Sheva | Netanya | Tel Aviv | Yavne | Kfar Saba |Italy :
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Rho |Japan :
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Almaty |Remote Korea :
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Warsaw |Remote :
Switzerland | Remote | Remote - Europe | Remote - Middle East | Remote, USA |Bucharest :
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Khulais | Najran | Rabigh | Riyadh | Jeddah | King Abdullah Economic City |Nišava District :
Niš |Singapore :
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Midrand |Brazil :
Sao paulo |South America :
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Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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