Local Safety Specialist

Monthly Basic Salary (Market related, Negotiable)

Our client based in Midrand, Johannesburg is seeking a Local Safety Specialist to join their team on a temporary basis. The incumbent is responsible for supporting Pharmacovigilance-related activities in South Africa and countries within the Sub-Saharan Africa cluster, as required by Marketing Authorization Holders (MAH) and/or study sponsors. The role ensures the maintenance of an appropriate PV vigilance system and Risk Management for products within its responsibilities. This includes proactive Benefit Risk Management throughout the product life cycle, translating global safety data to insights and actions tailored to local specificities and needs. The scope of the role includes support for Sub-Saharan Africa (Angola, Botswana, Lesotho, Malawi, Mozambique, Namibia, Swaziland, Tanzania, Uganda, Zambia, Zimbabwe, Seychelles, Cape Verde).

Main Responsibilities:

Local Medical Safety Responsibility & Benefit Risk Management:

• Establish product knowledge with a focus on safety profiles, therapeutic areas, and disease pathway knowledge supporting the needs of the local medical and marketing organization in collaboration with the International Medical Safety leader or MSO and the Country Safety team lead (CSTL)/Local Safety Officer (LSO) as applicable.

Aggregate Reports:

• Work with LSO/CSTL to provide medical input and insights for aggregate reports while undertaking a local review and ensuring the submission of Periodic Safety Update Reports (PSURs/DSURs), as applicable.
• Plan and ensure timely submission of Aggregate Reports according to local regulations.

Pharmacovigilance-Safety Training Support:

• Support LSO/CSTL in the preparation, conduct, and timely documentation of Pharmacovigilance training for Local Operating Company employees, and Adverse Event and Product Quality Complaints (AE/PQC) training to distributors/3rd-party vendors, including the translation of AE/PQC material where needed.

PV Contract Management:

• Support LSO/CSTL with the local Pharmacovigilance Agreements (PVAs) preparation and implementation, including Local Safety Unit (LSU) training and adherence to PVAs.
• Coordinate the provision of support for third-party safety agreements locally, e.g., local Vendor Agreements, as necessary, and seek support from central functions like PV Service and Technical Contracts Group and International PV (IPV) Affairs as needed.

Safety Regulations:

• Support CSTL/LSO in detecting and reporting PV regulatory requirements for MAH.
• Support in the review of new/revised safety regulations (for drugs, non-medicinal products, and medical devices in the scope of responsibilities), evaluate the impact on local processes, and notify appropriate global and regional groups via the central PV policy tracker (new requirements and/or updates).

Local Safety Compliance (PV and Non-Medicinal Product Safety):

• Provide insights on compliance metrics to CSTL/LSO.
• Support LSO/CSTL with CAPA implementation, procedural document review from Subject Matter Experts and Area leads, depending on the topic.
• Support in impact assessments and actions as required on a local level.
• Provide content to the Pharmacovigilance System Master File (PSMF) contributions and data, as needed, accurately and in a timely manner.
• Responsible for the local PSMF implementation and maintenance for countries of responsibility, where applicable.

Pharmacovigilance and Vigilance Service Provision:

• Collaborate with CSTL/LSO to ensure that day-to-day Pharmacovigilance and safety activities for non-medicinal products (i.e., cosmetics, medical devices, commodities, nutritional) are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company level, including adequate record management.

Job Requirements:

Qualification & Experience:

• Minimum of 1-2 years pharmacovigilance experience in the pharmaceutical industry.
• Degree/Advanced Degree in medicine or life sciences/Pharmacy (B. Pharm or D. Pharm) preferred.
• Knowledge and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• Proficiency in medical terminology (local languages).

Knowledge & Skills:

• Good verbal and written communication skills, fluency in local language(s) and English required.
• Good in data analysis and reporting.
• Proficiency in global and local SOPs.
• Ability to negotiate and communicate with internal and external customers.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Ability to manage multiple critical issues and work under pressure.