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Associate Manager, Ssa

5+ years
Preffered by Company
10 Aug. 26, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any Life Sciences 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

Are you passionate about ensuring the safety of pharmaceutical products? Do you have expertise in safety surveillance and pharmacovigilance? If you’re ready for a challenging and rewarding career, consider joining our Global Safety department at Novo Nordisk as an Associate Manager - Safety Surveillance Adviser. This is your opportunity to make a significant impact in a life-changing role.

Position Overview

As an Associate Manager - Safety Surveillance Adviser, you will play a crucial role in managing safety surveillance for both development and marketed products. You will oversee department activities, including coaching and mentoring your team, and drive continuous improvements in safety surveillance processes. Your responsibilities will include providing expert advice on safety information evaluation, managing patient risk activities, and collaborating with Global Development and Regulatory Affairs. You will also ensure compliance with external guidelines, set strategic direction, and create a motivational working environment.

Key Responsibilities

  • Leadership and Management: Lead and manage the department, including coaching, mentoring, and training staff. Ensure continuous improvement and adherence to safety surveillance responsibilities for assigned products.
  • Safety Surveillance: Develop and maintain procedures for ongoing surveillance, signal detection, and medical review of safety information. Secure compliance monitoring tools and systems for communicating safety issues and handling regulatory inquiries.
  • Collaboration: Work closely with Global Development and Regulatory Affairs on projects. Coordinate post-marketing regulatory reporting and pharmacovigilance activities. Negotiate contracts with external experts and CROs.
  • Compliance and Quality: Supervise safety committees, Data Monitoring Committees, and ensure adherence to Novo Nordisk's Quality system and Business Ethics.

Qualifications

  • Educational Background: Medical Degree (MBBS/MD) from a recognized medical school.
  • Experience: At least 5 years of experience in safety or clinical development within the pharmaceutical industry, including 2+ years in a leadership or project management role.
  • Knowledge: Proficiency in GMP and GCP, drug development, and life cycle management.
  • Skills: Strong experience with cross-functional collaboration, fluent in English, analytical mindset, and exceptional communication skills. Ability to plan proactively, demonstrate a quality mindset, and be a curious and flexible team player.

About the Department

The Global Safety - Global Business Services (GS-GBS) division, established in 2010, handles safety case processing from various sources, including spontaneous reports, literature, solicited reports, and clinical trials. Our team manages complete case processing, medical review, safety report submissions, training, quality control, Argus configuration, signal detection, risk mitigation, and literature surveillance.

Working at Novo Nordisk

Novo Nordisk is a global healthcare leader with a century-long legacy of combating chronic diseases. Building on our strong foundation in diabetes care, we are expanding our reach and impacting the lives of over 40 million patients worldwide. As one of the top 20 most valuable companies globally, we value the diverse skills and perspectives of our over 63,000 employees. At Novo Nordisk, we strive to be the best company for the world, and we believe that together, we can achieve life-changing results.

Application Process

To apply, please submit your CV and motivational letter online by clicking "Apply" and following the instructions.

Deadline: August 31, 2024

Disclaimer

Please be aware of fraudulent job offers that may appear to come from Novo Nordisk. We do not extend unsolicited employment offers or request personal information, equipment purchases, or funds as part of the recruitment process. For more information, please refer to our official recruitment guidelines.

Commitment to Diversity and Inclusion

Novo Nordisk is dedicated to creating an inclusive culture that celebrates diversity and supports equality of opportunity. We are committed to building a workforce that reflects the diverse communities we serve and the patients who rely on our products. Together, we’re making a difference.

Join us at Novo Nordisk. Together, we’re life changing.