Country Safety Team Lead Sa

2 weeks ago

Johannesburg, South Africa Johnson & Johnson Full time

**COUNTRY SAFETY TEAM LEAD SA & SSA**

**Location: Gauteng**

**Contract: Permanent
**Job purpose**
- Lead, manage and provide strategic direction to the cluster Local Medical Safety Team (LMS) team.
- Accountable for all strategic Pharmacovigilance (PV) activities for the Cluster
- Ensuring that the Local Operating Company Safety activities, related to medicinal and non-medicinal products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any Product vigilance agreements with third party business partners.
- Contact point in the country, internally and externally, for safety-related aspects.
- When required by local regulations act as a local Qualified Person for Pharmacovigilance (QPPV) or local responsible/contact person for PV.
- Have appropriate Pharmacovigilance and Risk management systems in place in order to assure appropriate oversight for products within its responsibility.
- The scope of the role and the countries the role will support, includes, Sub Saharan Africa (Angola, Botswana,, Lesotho, Malawi, Mozambique, Namibia, Swaziland, Tanzania, Uganda, Zambia, Zimbabwe, Seychelle, Cape Verde)

**The responsibilities & the impact YOU will have**:
**The main duties and responsibilities of the position are**:
**Leadership and Strategic Role**
Lead and manage the country/Cluster team.
- Ensure that the team provides input into global and regional strategies to provide optimal support for meeting regional and Cluster business objectives.
- Responsible for the leadership, development, and performance management of the country/Cluster team to achieve company objectives and culture. Develop and enhance the capabilities and capacities of the team through the identification and implementation of training and development needs.
- Where required by regulations, act as local contact or local QPPV, cooperating with the QPPV office, as appropriate and being active member of the Global QPPV Network. Manage local PSMF or equivalent document as needed.
- Maintain expertise in country/cluster as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the cluster.

**Internal Partnerships**

Develop strong partnerships within the country (e.g., Managing Director, Country Managers, Medical, Marketing, Regulatory Affairs, Legal, Business Quality, etc. across countries of the cluster
- Act as country’s point contact for Safety, internally and externally
- Support local, internal, and external safety activities in collaboration with internal and external stakeholders.
- Represent Pharmacovigilance in Cluster/country compliance forums or councils as applicable.
- Represent Pharmacovigilance as local Medical Safety Expert in Core Value Teams and business planning, as applicable.

**External Relationships**
- Represent pharmacovigilance and actively participate in local Pharma Association(s) and other external groups, and effectively communicate to key stakeholders of key issues that could impact PV strategies or the business.
- Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network. Respond to spontaneous requests from authorities Acting within the local Pharma Association
- Collaborate with authorities in order to impact pharmacovigilance standards in cluster/country.

**Operational Excellence**

Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.
- **Efficient, high-quality execution of safety-related activities**
- **Performance towards corporate functions and local compliance towards regulatory bodies**
- **Efficient management of resources in the Safety Unit**

**In detail**:

- Effectively collaborate with Regional IPV Affairs & Case Management teams to manage workload, as applicable.
- Continuous improvement of safety culture
- Participate in global/regional projects and working groups, as applicable.
- Develop and maintain knowledge of applicable SOPs and other procedural documentation.
- Manage and monitor the effective rollout of processes.
- Facilitate resolution of concerns and questions
- Ensure fulfilling of drug safety-related obligations for the country/cluster in compliance with company standards and international/local regulations.
- Ensure timely and accurate handling of individual and aggregate safety reports to meet corporate and regulatory reporting requirements for the country/cluster.
- Ensure timely handling of local safety issues; manage local safety issues in collaboration with global safety functions and local stakeholders.
- Ensure adequate local signal detection process, if required, and ensure reporting of potential single case signals or clusters of similar events seen in case processing, as applicable and in collaboration with Case management team.
- Support timely handling of local safety-rela

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