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 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 positions;
Regulatory Affairs Specialist:
(Ref No. 2013/HR/BHC-001)
Reporting to the Head of Regulatory Affairs Middle Africa region, the Regulatory Affairs Specialist’s position purpose will be theregistration / re-registration of company Healthcare products.
Major Tasks of the Position
- Monitors
the country’s requirements of registration and quality control of
medicinal products and timely informs Head of Regulatory Affairs and all
departments on changes connected with product portfolio promotion and
sales;
- Supports
contacts with Ministry of Health and other authorities and the
organizations participating in registration, expertise and quality control
of medicinal products;
- Works
out registration / re-registrations plan together with Head of Regulatory
Affairs and Regulatory Affairs Manager;
- Supports
duly registration / re-registration of product portfolio of the company,
subsidiaries and if necessary companiespartners defined by Head of
Regulatory Affairs in Kenya coordinating actions with Regulatory Affairs
Manager
- Ensures
timely modification of NDA (when necessary) under laws and other acts as
stipulated in the respective country
- Provides
Representation offices and branches of countries depending on the country
with approved documents,registration certificates, NDA, leaflets,
packaging, etc;
Education/Skills
- University
degree in natural science (pharmacy is preferable);
- Minimum
3 years of work experience in medical products registration;
- High
level of knowledge of the Company and competitors product portfolio;
- Good
knowledge of legislative and other standard documents in the sphere of
registration and certification of pharmaceutical products;
- Analytical
and conception thinking;
- Punctuality
and duty performance;
- Ability
to work under stress;
- Good
command of English (both oral and written);
- Advanced
user of PC: MS Windows, Internet;
- Readiness
to business travel.
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 overallaccountability 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
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)