Job Purpose Statement:
- Responsible for overall medical governance for Vaccines, Pharma and Consumer products marketed in East Africa Pharma and Biological clinical trials and Pharmacovigilance activities for marketed and investigational products
- Implement allocated designated clinical trials in accordance with international and local legal requirements and guidelines
- Provide medical support to marketing and regulatory affairs departments
- Provide medical department management
Scope:
The medical department comprises of clinical research, medical affairs and pharmacovigilance.
Essential Job Responsibilities:
- Accountable for the governance oversight and implementation of Scientific Engagement principles and operating practices
- To secure clinical Research and Development for East Africa by ongoing interactions with central research divisions, regulatory authorities, key opinion leaders and investigators to ensure continued involvement in international multicentre clinical trials.
- To undertake clinical trials in East Africa by engaging and developing capable investigators and clinical trial sites and trial staff
- To understand patient-population, demography and dynamics.
- To negotiate and manage clinical trial legal agreements and budgets between the investigators and company
- To conduct clinical trials in accordance with ICH, GCP and local Ethics Committees and legislation.
- To provide medical support to the marketing division to ensure successful commercialisation of products throughout their life cycles.
- To review and approve promotional materials to agreed SOP taking into account latest codes of conduct.
- To provide a robust Medical Information Service to both internal and external customers.
- To supply and maintain a compassionate use programme of unregistered products in accordance with legislation and clinical need.
- To ensure training including Adverse Events and Promotional Code is conducted at induction for all new staff
- To maintain a drug safety reporting system in accordance with and legislative requirements as Person Responsible for Pharmacovigilance (PRP) for East Africa
- As PRP for East Africa, have overall accountability for pharmacovigilance, materiovigilance and human safety related activities for all marketed products and products in clinical trials, including all Pharma products, vaccines and Consumer Healthcare products.
- To ensure ongoing self-development and training in order to maintain excellent personal performance necessary to maintain our image as a leader in research and development.
- To consistently identify issues not noticed or passed over by others and develop own plans for assessing situation, gathering others view (at International or global level), then putting in place the connections for a matrix approach to a project to resolve the issue
- Must consistently demonstrate a high level of indirect influencing – be able to get cooperation and participation from SVP to LOC advisor
- To drive projects to conclusion with a high degree of autonomy; set sensible timelines, and hold others to them in an organised way
- High in making operational decisions
Qualifications:
- MB.ChB
- Post graduate management or business qualification or industry experience
- Good interpersonal skills
- Academic credibility with target audience/s
- Pharmaceutical industry qualification (pharmacology/pharmaceutical medicine) and experience
Preferred Requirements:
- Professional medical knowledge
- Knowledge on all clinical trial regulatory requirements
- Knowledge of all clinical trial requirements