• Ensure compliance with GSK Code of Practices, and local SOPs
• Support proper conduct of clinical studies in compliance with Good clinical Practice and GSK’s policies in WCA, and local Surveillance programmes in WCA
• Back-up the Named Safety Contact (NSC back up) in day to day management of Pharmacovigilance activities
• Act as a resource to commercial and marketing Dpt
• Back-up the ZincMaps and Medical Information champion
• To support the set up, conduct and follow up of clinical trials within the region
• Follow up antimicrobial surveillance testing programs and surveys initiated in the region and by commercial (SOAR)
• As NSC Back-up (Named Safety Contact) for WCA, support the day to day management of pharmacovigilance for all marketed products and products in clinical trials, including all Pharma products and Vaccines. This includes ensuring compliance with all local regulations and GSK global pharmacovigilance requirements, and includes training staff on AE reporting
• To ensure training of sales force on pathology and treatments
• To ensure the review of promotional and training materials
• To ensure the handling of internal and external medical/scientific information queries/requests, and the maintenance of an appropriate medical intelligence across the whole WCA
• To support the management of departmental local SOPs
• To ensure the Self Inspection of all activities
• To ensure the handling of medical meetings in compliance with GSK SOPs and Policies and Scientific engagement guidelines
1. responsibility for handling medical information enquiries from internal and external sources
2. accountability for ensuring compliance with local regulations, Good Clinical Practices and GSK policies in the conduct of clinical trials
3. Scientific / medical suitable trainings and refreshments for the commercial department
• Ability to meet notification and reporting deadlines in any case
• Focus on several key activities in one time period
• Ability to work in matrix teams
• Ability to have good relationship with key customers, KOLs, KDMs
• Strong medical background
• Strong leadership skills and drive + passion for results Integrity and Professionalism
• Capacity to think strategically – identifying opportunities and rectifying problems through lateral thinking.
- Creating business solution in a rapidly evolving regulatory environment.
- Strong interpersonal skills and team player.
- Anticipation of a constantly changing environment and the use of scenario planning as a tool to plan for an uncertain future.
- Sound judgment and Patient Focus
- Capacity to work autonomously and concern for Achievement
- Knowledge of local legislations.
- Effective communication and leverage network connections.
• Proficiency in the use of computer software applications e.g. Microsoft Excel, Microsoft PowerPoint etc.
• Suitable English and French speaking and writing skills