Medical Governance Officer

Bayer HealthCare (BHC), a division of Bayer East Africa Ltd, combines the global activities of the divisions Animal Health, Pharmaceuticals, Consumer Care and Medical Care. Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

In Middle Africa, BHC is present in 41 countries, with its head office in Nairobi, Kenya.
To maximise our commitment to sustainable medical health development, provide innovative products, medical solutions and stewardship through product life-cycle management, we seek to recruit qualified and result oriented individuals to fill the following position;


Medical Governance Officer: (Ref No. 2013/HR/BHC-002)

Reporting to the Country Medical Director-Middle Africa, Medical Governance Officer’s position purpose will be the overall accountability for the medical governance in Middle Africa, encompassing all Pharmaceutical business.

The MGO will be expected to develop and direct the medical governance function in the region by installing medical structures, ensuring medical governance and compliance with International Pharmaceutical Standards, BHC Standard Operating Procedures (SOPs), IFMA Code of Pharmaceutical Marketing Practice and others as applicable pharmaceutical codes.

Support the business and foster the business growth of the Country subsidiary by developing and implementing medical and clinical processes and activities in alliance with the overall BSP strategy. The MGO is expected to provide a source of expertise to advice on medical governance of the conduct of promotional and non-promotional activities and to represent the company at Pharma associations and regulatory bodies.

The MGO will support cross-functional support between the Medical Department and the local Marketing and Sales Departments. Every avenue must be explored to ensure that cross-functional working of this nature produces the optimal conditions in terms of business efficiency, staff morale and high quality output.

Education/Skills
• Degree in Medicine. Must be a registered with the Medical and Dentists Practitioners Board and have a current Practicing License.
• 4 years post registration experience. Experience in the Pharmaceutical Industry will be a definite advantage.
• Familiar with at least one therapeutic area indication including epidemiology, disease patterns and therapeutic options.
• Knowledge of international pharmaceutical laws, standards and codices.
• Familiarity with current local and ICH guidelines and regulations
• Highly committed, complexity-solving personality, with demonstrated ethical medical decision making skills
• Excellent communication skills, both verbal and in written. Excellent command of country language
• Knowledge of French will be an added advantage
• Outstanding leadership and inter-personal skills, ability to work well in teams
3. Pharmacovigilance Country Head (PVCH): Ref No. 2013/HR/BHC-003)
Reporting to the Country Medical Director, the PVCH is responsible for Pharmacovigilance in the Middle Africa region working towards excellence to ensure the safe and appropriate use and the long-term medical potential of company’s products.

Major Tasks of the Position
• Directs, manages and improves all Pharmacovigilance activities for all BHC products according to the specific country’s legislation and as devolved from Global Pharmacovigilance.
• The PVCH provides medical safety governance to protect the patients; the products and the Bayer HealthCare Group with special focus on the each country’s public health needs. The PVCH assures compliance with national and relevant international drug safety regulations.
• Assures the collection, review, processing and distribution of adverse event information on a country level regarding the Bayer products in all therapeutic areas and submission to Health Authorities according to the local regulations.
• Responsibility for local safety issue and crisis management in collaboration with the Headquarter.
• Reviews the PV components of all domestic study protocols and informed consents and ensures that these parts are compliant with the GPV standards and the protocol template
• Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. market research, Active-Online-Listening) to ensure Pharmacovigilance principles are applied in the interaction with patients.
• Leads the local Safety Management Team (SMT) and liaises with the relevant expert functions in the local Safety Risk Management Plans (RMP) development and intervention implementation activities

Education/Skills
• Bachelor of Pharmacy degree (B. Pharm)
• Registered as a Pharmacist by the Pharmacy & Poisons Board, with a current Annual Practice Licence;
• A minimum of 3 years’ experience in a healthcare organization, especially Clinical Development, Medical Affairs or Pharmacovigilance.
• In-depth experience in drug development process over different stages, especially clinical development and clinical operations
• Highly effective communicator with strong influencing ability and communication skills
• Demonstrated ability to function effectively and successfully in a complex multicultural environment
• Experience of working across and building effective working relationships between functions
• Organized, able to multi-task effectively
• Good command of English language (both oral and written), knowledge of French language is an added advantage;
• Good Computer literacy
• Readiness to business travel


How to apply:
If you meet the above requirements, please send your application letter, a detailed CV with three professional referees including daytime contact, copies of certificates and testimonials (quoting the reference number on both application letter and envelop) not later than 3rd April 2013 to:

The Human Resources Manager, Bayer East Africa Ltd, PO Box 30321 – 00100 GPO, Nairobi. E-mail: hr.ke@bayer.com

(Applications received after the deadline will not be considered. Only short-listed candidates will be contacted)