Dear Job Seekers,
Hiring for Novo Nordisk
Job Title: Safety Surveillance Adviser
- The position As a Safety Surveillance Adviser I you develop and update the minimum mandatory safety information (MMSI) for use in the Informed Consent, and act as owner of the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products and also manage maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer. Perform ongoing and systematic surveillance of all accessible data within allocated product area(s), take initial actions to mitigate risks in case a safety signal or alert is detected or aggravated and document the results of the safety surveillance for the period.
- Conduct periodic literature surveillance for marketed products and for development products (if applicable) and also as author prepare Development Safety Update Reports (DSURs), periodic Serious Unexpected Serious
- Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by HAs. To be involved in responding to requests from HAs and providing support with internal requests.
- Additionally, conduct product training within therapeutic area of responsibility. Establish, operate and chair the safety committee throughout lifecycle of the actual product present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations. And also be responsible for all areas related to patient safety in clinical trials by providing safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator Brochure (IB), integrated safety summaries, abstracts and planned publications, provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct
- Investigator training as required, provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs) and finally establish and ensure deliverables to/from Data Monitoring Committees (DMCs) Qualifications: You need to have the below knowledge, skills and experience. University degree in Medical (MBBS, MD or MBBS, and post graduate degree) Key Professional Competencies Pathophysiology Clinical Pharmacology Clinical experience (diagnose/treatment)
- Basic statistics Scientific methodology Analysis of data Drug development PV Master degree with preferably 2+years of relevant working experience within some of the key professional competencies
- Comfortable user of Microsoft office package (Outlook, Word, Excel and PowerPoint)
- Fluent in written and spoken English Analytical mind-set Professional authority Quality mind-set, well-organised and strive for excellence
- Pro-active planner to meet agreed deliverables Strong communicator (verbally and in writing)
- Curious and constantly looking for improvement opportunities Team player with high degree of flexibility and service mindedness
- Cross-cultural awareness
- Ability and willingness to quickly adjust to changes in a continuously developing environment Working at Novo Nordisk At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Experience: 2+ years
Salary: As per the Company Standards