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Medical Information - Drug Safety Project Manager - Belgium
Keyrus Biopharma (company)
Posted on : 18 May 2017
- We are looking for a Medical Information Drug Safety Project Manager.
- The Medical Information organization varies from one country to another.
- In some countries; it is well defined and in other countries the resources are very limited and the Client's teams may have multiple functions/roles.
- A Global Medical Information System to record and track the unsolicited medical information is implemented in all Client's Affiliates; although it is not well used in certain countries where the resources are limited.
Role and main tasks:
This Drug Safety project manager will:
- Lead and manage the project to deliver a CAPA Plan that will be agreed by Pharmacovigilance and Quality Assurance including the root causes analysis.
- Review current SOPs to understand the Medical Information Practices
- Analyze the audit findings and assign them to the 4 work-streams
- Provide a CAPA Plan that will be agreed by PV QA manager
- Support the work streams in the Root cause analysis, the planning of the actions and deliverables
- Investigate, define and document the Root causes of the audit findings within each work stream
- Identify and document the corrective, and preventive actions within each work stream
- Define the owner of the actions, timelines and deliverables for the actions in each work stream
- Coordinate, document the work stream outputs and meetings
- Integrate and align the CAPA Plan with the existing Medinfo CAPAs identified at the affiliates or partners
- Strong project management, organizational and analytical skills in addition to a well-developed interpersonal and team working skills are key.
- Communication skills and excellent command of the verbal and written English (if possible in addition to French) will be essential.
- Previous experience in managing global projects with several work streams including cross functional team members in the area of Medical Information and Safety is required.
- Good understanding of the Medical Information, Regulatory, and Safety regulations and Compliance is an asset.
- Advanced project management by using IT systems to keep track of progress would also be beneficial.
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.