GBLCAREERS

Safety and Medical Operations Officer > Close Date: 27-Jun-2013
Summary

Job Title Safety and Medical Operations Officer
Location – Town / City Bryanston
Location – Country South Africa
Reporting To (Job Title) Head of Medical
Type of position Permanent
Job Advert
Job Purpose/Scope Job Purpose:
1.Management of Pharmacovigilance for the whole Southern Africa region
2.Pharmacovigilance support to all departments of the Southern Africa Business Unit
3.Building a network environment for Pharmacovigilance with all National Regulatory Authorities (or similar governing bodies) in all countries under the Southern Africa LOC
4.Support and oversight of all safety matters/activites related to designated clinical trials in accordance with international and local legal and regulatory requirements and guidelines
5.Management of Medical Operations for the Southern Africa Medical Department

Scope:
No. of people reporting to Safety and Medical Operations Officer: 0

Countries of responsibility: Angola, Botswana, Comoros, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, Zambia and Zimbabwe
Key Responsibilities Essential Job Responsibilities:
1.As the Safety and Medical Operations Officer, has overall responsibility for the day to day management of Pharmacovigilance (PV) for all marketed products and products in clinical trials (involving Southern Africa countries), including all Pharma and Vaccine products, which include, but not limited to:
1.1.Collection of adverse events (AEs), and follow-up actions, recording in the country register and reporting of the AEs to Central Safety Departments
1.2.Timely reporting of AEs/SAEs to the local regulatory authority as required
1.3.Submission of PSURs/DSURs/PSRIs and other periodic safety updates to regulatory authorities
1.4.Training of all SnA LOC staff and relevant 3rd Party Partner Company staff on AE Reporting
1.5.Maintenance of the SnA LOC Pharmacovigilance SOP and training of SnA Pharma and Consumer Healthcare staff on the SOP
1.6.Conduct PV awareness campaign activities

2.Ensure compliance with all local regulations and GSK global Pharmacovigilance requirements
2.1.Engage NRAs on Pharmacovigilance regulations for the collation of, and continual review of, all country PV regulations and ensure timely adherence to the requirements
2.2.Participate in national PV readiness activities for the countries
2.3.Become a GSK representative on the PIASA PV Forum

3.Overall responsibility for maintenance of PV tracking systems to ensure that SnA is compliant with all Safety and Medical Governance requirements. These include, but not limited to:
3.1.Local AE reporting system (LOCALE)
3.2.Provision of Medical Information and maintenance of the Medical Information system (WISDoM)
3.3.Clinical Trial SAE reporting systems (e-Clinipix and RDE)
3.4.Global AE reporting systems (CIOMS 1 Reporting Module – for the purposes of expedited reporting)
3.5.Out of Hours Reporting Log and Literature Search Log
3.6.GCSP SDEA Database
3.7.PSUR tracking log and PSRI tracking log
3.8.HCP High Risk 3rd Party Tracker
3.9.ZINC Maps Department Champion
3.10.SnA training logs
3.11.3rd party safety reconciliation tracker
3.12.Input into the PV System Masterfile

4.Provision of Medical Information to HCPs, maintenance of the Medical Information system (WISDoM)(e.g. product lists per country etc) and provision of associated WISDoM metrics to Global Medical Information team

5.SOP Administration for Medical Department
5.1.Monitoring SOP review and approval times
5.2.Archiving of SOPs

6.Conduct Level 1 and 2 self-audits for PV compliance monitoring

7.Management of HCP engagement agreements

8.Overall training on PV for SnA staff members
Qualifications, Experience •Scientifically based undergraduate degree (e.g. Nursing, Pharmacy etc)
•Post graduate management qualification or industry experience an added advantage
•Good interpersonal skills
Competencies Job Factors:

Knowledge:
•Current professional scientific knowledge
•Current knowledge on all clinical trial regulatory requirements where relevant
•Current knowledge of all GSK’s clinical trial requirements where relevant
•Current knowledge of statuary requirements and codes of industry governing
•Current knowledge of generic and project management needs
•Computer Literacy

Complexity:
•To manage adverse events including deaths in all GSK products
•To promote the development of private-public-partnerships with the Ministries of Health/NRAs
Independent Thinking: (Provide examples of innovations or creative approaches used and indicate the frequency with which they are performed. Indicate the degree to which this position is governed by procedures and standards).
•To negotiate, implement and conclude all safety-relevant issues between GSK, investigators, staff and regulatory authorities in compliance with GSK standards within tight timelines and budgets.
•Communication with consumers/patients with GSK product or therapeutic area queries/reports.

Responsibility:
1.To conduct all duties in accordance with GSK international and Southern African countries’ standards.
2.To ensure compliance with all local regulations and GSK global pharmacovigilance requirements
3.To vigorously defend products in line with legislation and codes.
4.To report to the Head of Medical, Southern Africa
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