Clinical Safety Manager at GlaxoSmithKline (GSK)

ViiV Healthcare is a dynamic, independent company 100% focused on delivering new treatments to people living with HIV.
This role offers the opportunity to become a member of the ViiV central safety team while working with the ViiV regional medical team in Africa, a team of passionate individuals committed to delivering advances in HIV therapy.
As part of the global organisation of Global Medical and Research and Development (RDGM), the role-holder will work with the safety team to deliver key Safety and Pharmacovigilance (PV) objectives related to PV activities in the region of Africa.
The role is based in South Africa, Bryanston.
The primary responsibility of this role is the enhancement, co-ordination and maintenance of ViiV PV activities in Africa in order to improve reporting and collection of adverse events for ViiV products in this region.

Key Responsibilities

• Point of contact for ViiV in PV matters related to the African region including
• Engagement with internal stakeholders (such as ViiV and GSK medical and safety teams) and relevant external parties and organisations
• Coordinate planning and lead delivery of ViiV-initiated PV activities in African countries
• Represent ViiV safety at meetings with internal and external stakeholders as appropriate related to ViiV Africa PV project
• Work with multiple stakeholders within ViiV and GSK to develop and deliver PV training materials for agreed target audience in these countries, where appropriate deliver training
• Accountable for delivery of agreed activities and in a timely manner
• Establishing KPIs for adverse event reporting and monitoring of set targets
• Development of PV related processes supporting adverse event collection from the region
• Work collaboratively with relevant GSK/ViiV and external teams to develop appropriate reporting tools/forms
• Provide ongoing support for the local ViiV medical teams in PV related activities

Required Qualification And Experience

• University graduate of a science degree or Masters in a medically related discipline.
• Pharmacovigilance and/or regulatory experience (min. 5 years) with exposure to and knowledge of PV regulatory requirements in Africa. Experience in project management is desirable.

Required Skills

• Good communication skills (including technical/clinical writing skills and verbal communication)
• Good IT skills including, but not limited to Word, Excel, Outlook, SharePoint
• Excellent organisation skills and sense of urgency/working to tight timelines
• Attention to detail
• Ability to navigate complex projects and interact in a matrix environment
• Demonstrated ownership of projects and tasks
• Development and/or implementation of process improvement initiatives
• Have a flexible approach
• Confident in interacting with people within and outside the organisation