1. Job Scope:
The Associate Head Medical Affairs will ensure accountability on both the activities and colleagues working in the area of Medical Affairs, PV, Regulatory (Medical Information, Drug Safety, Regulatory, PV, Expanded access programs) in Belgium and Luxembourg. Aim is to gradually expand the responsibilities to ultimately Medical Affairs Lead in a relatively short term.
2. Responsibilities:
People Management
- Coach, share learnings and be back-up within the medical shared services team (4-5 direct reports)
- Discuss issues and strengths within the team and handle issues/problems as appropriate
- Track and inquire on process quality deviations
- Actively participate in recruitment, diversity, and retention and hiring efforts
Medical Affairs
- Become familiar with the company's therapeutic domains and med affairs tasks
- Understand Belgian health care organization
- Provide expert medical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company
- Support to strategy and provide medical expertise in price & reimbursement dossiers
- Liaise with Belgian clinical operation manager
- Contribute to the development of medical strategies to support brand commercialization activities by working closely with the cross-functional management
- Contribute actively on an ongoing basis to the strategic planning for currently marketed brands
- Support training of sales representatives, and other medical representatives
- Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community
Pharmacovigilance
- Supervise Adverse Events (AE) and Product Complaint (PC) management
- Function as the national nominated contact person for pharmacovigilance
Information and Publicity
- Be (or become) the RIP
- Participate to policy redaction, governance and training of stakeholders on the good promotion/deontological/anti-bribery legal guidelines
- Understand and ensure compliance to local and international regulations, guidances and laws, company standards and SOPs, company integrity agreements and quality
Communication / Reporting
- Represent the interest of medical shared services in internal meetings when applicable
- Communicate with the business teams on relevant topics (e.g. change in strategies/updates on submissions/safety concerns)
Regulatory
- Ensure submission, follow-up and maintenance of Medical Need Programs
Affiliate Tasks
- Represent the Medical Departement at external meetings and towards external associations or official bodies (Pharma.be, FAMHP…)
- Contribute to affiliate risk assessment, policy development and awareness linked to the respective domains of promotional practices, int