Medical Execellence Manager at RS Hunter Limited

Job Description
Purpose Statement:

•     Ensure compliance with corporate and regulatory obligations regarding the safety of all the organization’s products. Partners the commercial organization through integrated medical and scientific support and provide the scientific competence needed to ensure that the organization’s products reach their full commercial potential and respect the ethics.
•     Provide to the Nigeria-Ghana affiliate the expertise in the field of medical excellence, Pharmacovigilance and clinical operations and coordinate the activity.
•     Lead and coordinate the implementation and maintenance of an appropriate Affiliate Quality System in Nigeria-Ghana  in compliance with the organization’s Quality Policy concerning all activities related to the clinical investigation, distribution and marketing of all products developed and/or marketed in the country by the organization or through partnership agreement

Key Accountabilities:
Affiliate Pharmacovigilance Head (APH) 
The APH is responsible to ensure that resources, training, systems, procedures and tools are implemented to fulfill the following:

•     Processes to comply with local PV regulations, Global GPE SOPs are implemented and documented locally.
•     Training regarding PV business needs is performed locally to all stakeholders including sales force.
•     Tracking of reporting activities is performed.
•     Handle appropriately ICSRs and other PV data received locally to comply with GPE global SOPs and local regulatory PV requirements.
•     Monitor daily incoming communication (e.g., e-mail, post, telephone, and fax) for potential Pharmacovigilance information.
•     Ensure that processes are in place to receive ICSRs in a timely manner from other functions/groups within the affiliate (e.g., sales representatives, medical information, or any other group that has first contact with a reporter). Reconciliation should be performed periodically to ensure the transfer of this information to the APH.
•     If needed, handle appropriately locally periodic reports including PSRs, periodic reviews and product safety alerts to comply with GPE global SOPs and local regulatory PV requirements.
•     Responsible to inform GPE of the local regulatory reporting requirements and to ensure timely reporting in compliance with these regulations.
•     Coordinate and manage local PV Alerts in collaboration with GPE and local Management.
•     Promote the PV with internal and external stakeholders in collaboration with Health Authorities and participate to dedicated working groups

Nigeria-Ghana Medical Excellence

•     Ensure development & updating local medical and regulatory affairs SOPs
•     Review of the SOPs developed by the Clinical Operation / DRA.
•     Ensure that the Medical & Regulatory Staff are trained on the relevant SOPs.
•     Training for the newly hired Medical staff on the relevant SOPs.
•     Manage the medical quality function through auditing various medical activities to ensure the implementation of SOPs.
•     Perform ad hoc audits when needed.
•     Follow up on the corrective action plan for the recommendation of audits.
•     Responsible for the training of the partners of the medical department on the relevant SOPs e.g. Promotional Materials approval, Good promotional practices, etc.
•     Implement and coordinate the approval process for Promotional materials within the  affiliate
•     Ensure that Patient Support Programs (PSPs) are complying with SOPs and guidelines.
•     Coordinate and elaborate the ITC medical dashboard report.

Clinical Operations for Nigeria-Ghana

•     Ensure that all SOPs are implemented and GCPs are applied.
•     Cross fertilized the clinical study through the 2 affiliates in order to have common protocols and validate the synopsis.
•     Follow-up the clinical studies and fill Clear and Club-net data base accordingly.
•     Ensure that Clinical Study Reports (CSRs) are done as well as publications.

Affiliate Quality Officer (AQO) for Nigeria-Ghana

•     Quality leader in affiliate
•     Product quality events (beyond manufacturing): Product Technical Complaints, Recalls, Notifications to/from Authorities
•     Quality system on all GxP and health-regulated activities
•     Annual Affiliate quality reviews & related report
•     Quality risk management Quality oversight of local third party suppliers/sub-contractors
•     Quality agreements with suppliers (including Sanofi manufacturing sites)
•     Inspection readiness support

Skills:
A Physician/Pharmacist with Postgraduate studies as master, MBA is preferred. At least 5 years Medical experience in a pharmaceutical environment.

•     Pharmacovigilance Experience
•     Knowledge of relevant Regulations, Guidelines, Good Practices, both national, regional and international applicable to affiliate operations
•     Overview of pharmaceutical business in Africa and marketing knowledge.
•     Autonomy with confirmed sense of urgency, priorities & self-control, capacity for problem solving
•     Ability to interact efficiently with Competent Authorities/ Inspectorates.
•     Leadership skills, with appropriate level of flexibility and reactivity and ability to act quickly with negotiation skills.
•     Ability to work transversely in a matrix organization & to foster a process simplification approach while meeting compliance requirements
•     Strong presentation and communication skills.
•     Objective driven and detailed Oriented
•     Fluent English language.
•     Computer knowledge.