A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: RMP Documantation Expert
Job Description
Manage the timely and accurate completion of EU RMP Annex 1 using the appropriate software, in the required timelines and according to the required technical standards.
- Function as the RMP Annex 1 expert within Novartis organizing meetings as required and providing advice / expertise on MedDRA structure and EMA’s requirements for Annex 1.
- Develop and provide training on EU RMP Annex 1 activities and responsibilities for the relevant Safety Management Team members (BSLs, PVLs, PVEs) as required.
- Facilitate all CREDI processes for RMP documents and provide guidance as required to DS&E associates in respect of use of CREDI for DS&E documents.
- Perform technical / quality review of RMP documents to ensure compliance of documents imported into CREDI with HA regulations (e-CTD standards).
- Perform technical / quality review of RMP documents to ensure compliance for regulatory submission, e.g. NovStyle review in accordance with Novstyle guidelines.
- Ensure technical compliance of documents imported in CREDI with HA regulations (e-CTD standards)
- Contributes to continuous improvement for the preparation of RMPs, including the review of Business Guidance and Standard Operating Procedures documents
- Manage RMP databases / sites / systems as requested by the Head of Safety RMP office.
- Manage timely and accurate preparation of EU Risk Management Plan (RMP) Annex 1 for EU regulatory submission and to complete important RMP document management activities, including technical compliance assurance (e.g. with e-CTD standards), quality checking, resource maintenance (e.g. RMP sites / systems).
- Ensures documents submitted to EMA within stipulated timelines and in accordance with technical requirements.
- Ensure current versions of all key RMP documents are available to organization (including other sectors) at all times
Candidate Profile
Ideally at least 1 year experience in drug safety / drug regulatory affairs / clinical research.
- Team worker.
- Communicative and collaborative.
- Can demonstrate ability to work with cross-functional teams in complex projects.
- Effective worker who is able to establish relationships with colleagues / stakeholders.
- Solid computer technical skills and ability to learn new technical systems quickly.
- Some knowledge in European and other regulatory requirements / concepts for drug registration would be beneficial.
Additional Information:
Job ID: 190129BR
Experience: 0-1 Year
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 20th July, 2016
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