Senior Area/Local Safety Officer Consultant

Job Description

ClinChoice is seeking a Senior Area/Local Safety Officer Consultant for a 12-month contract, potentially extendable, to work directly with a single sponsor while benefiting from the stability of a global CRO. This hybrid role, based in Cape Town, South Africa, requires 2-3 days per week onsite.The Senior Area Safety Officer will oversee local operating company (LOC) safety activities related to all products, ensuring compliance with local regulations and company policies at local, regional, and global levels. This includes managing product vigilance in accordance with agreements with third-party business partners. The role serves as the main point of contact for pharmacovigilance matters, including cosmetovigilance, materiovigilance, and nutrivigilance, with local health authorities.Responsibilities:

• Oversight of the PV System & Overall responsibilities
• Provide oversight of vendor resources within AMET
• Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).
• Receive and support the Area Safety Head in the responses to safety-related health authority queries.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.
• Perform document management and archiving as required.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
• Manage reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments as applicable.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance, including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
• Ensure pharmacovigilance compliance of local company sponsored programs and research activities as applicable.
• Perform translation for ICSR and PV-related documents, as required.
• Provide technical and strategic input and participate in projects/ workstreams led by the Medical Safety teams or LOC
• Develop, update, and implement local procedures to ensure compliance with global procedures and national requirements.
• Ensure current knowledge of all relevant company procedures and training.
• Support local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA plans as applicable.
• Management of PV clauses to be included within local agreements.
• Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).

Requirements:

• Health care science professional e.g.: (Physician, Pharmacist)
• At minimum 3 years’ experience.
• Pharmaceutical industry experiences including product vigilance responsibility role.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.
• Proven ability to organize workflow activities.
• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• Knowledge of global, regional, and local procedural documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Good verbal and written communication skills.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of all local requirements and of global aspects of product safety.
• Fluency in the English language.

ClinChoice offers:

• Opportunity to work directly for a single sponsor.
• Security and career opportunities of a global CRO.
• A supportive culture focused on quality and professional development.