Senior Area / Local Safety Officer Consultant

Clinchoice; Cape Town; On-site; ZAR 600,000 - 850,000; Full time

Job summary

A global CRO is seeking a Senior Area / Local Safety Officer Consultant for a 12-month contract based in Cape Town. The role will oversee pharmacovigilance activities, ensuring compliance with safety regulations and liaising with health authorities. Candidates should possess minimum 3 years of experience in the pharmaceutical industry and be capable of fostering trustful relationships with client teams.

Qualifications

• Minimum 3 years' experience in the pharmaceutical industry with product vigilance responsibilities.
• Knowledge of medicine, pharmacy, clinical practice, or related fields.

Responsibilities

• Oversee the Pharmacovigilance (PV) system and overall responsibilities.
• Manage safety report submissions (SAE, SUSARs, PSUR, RMP, etc.).
• Ensure compliance of sponsored programs and research activities.

Skills

Communication

Relationship Building

Organization

Fluency in English

Education

Healthcare science professional (Physician, Pharmacist, etc.)

Tools

IT safety systems

Job description

Senior Area / Local Safety Officer Consultant

ClinChoice is seeking a Senior Area / Local Safety Officer Consultant for a 12-month contract, with potential for extension, to join our client. This role involves ensuring compliance with local regulations and company policies related to safety activities for all products at the local, regional, and global levels, including product vigilance agreements with third-party partners.

The Senior Area Safety Officer serves as the primary contact for pharmacovigilance matters, including Cosmetovigilance, Materiovigilance, and Nutrivigilance, liaising with local health authorities. They will oversee product vigilance and risk management systems within their responsibility.

This client-facing role requires confident candidates who can work independently and build trustful relationships with client teams.

Main Responsibilities:

1. Oversight of the Pharmacovigilance (PV) system and overall responsibilities.
2. Provide oversight of vendor resources within the AMET region.
3. Support the Area Safety Head with local information for the European Economic Area / UK Pharmacovigilance System Master Files.
4. Record non-conformances, investigate, and implement Corrective and Preventive Actions (CAPAs).
5. Support responses to safety-related health authority queries.
6. Perform reconciliation with internal and external stakeholders.
7. Maintain oversight of literature articles for adverse event reporting.
8. Manage document control and archiving.
9. Ensure safety reporting training and awareness among LOC personnel.
10. Monitor regulatory impacts on vigilance activities.
11. Collaborate on safety issue notifications to local authorities.
12. Manage safety report submissions (SAE, SUSARs, PSUR, RMP, etc.).
13. Stay updated on local pharmacovigilance requirements and implement process changes.
14. Ensure compliance of sponsored programs and research activities.
15. Translate ICSR and PV documents as needed.
16. Participate in projects led by Medical Safety teams.
17. Develop and update local procedures to ensure compliance.
18. Support inspections and audits, responding to queries and developing CAPAs.
19. Manage PV clauses in local agreements.
20. Implement local business continuity plans.

Qualifications and Experience:

• Healthcare science professional (Physician, Pharmacist, etc.).
• Minimum 3 years' experience in the pharmaceutical industry with product vigilance responsibilities.
• Knowledge of medicine, pharmacy, clinical practice, or related fields.
• Ability to organize workflow activities.
• Understanding of product vigilance, drug development, pharmacology.
• Familiarity with global, regional, and local procedural documents.
• Computer literacy with relevant IT safety systems.
• Strong communication skills.
• Ability to build relationships within the organization and with authorities.
• Knowledge of local and global safety requirements.
• Fluency in English.

Application Process:

After submitting your CV, you'll receive an acknowledgment. If you meet our requirements, you'll be invited for a phone interview. Due to high volume, we cannot respond to all applicants individually.

About ClinChoice:

ClinChoice is a global CRO with over 28 years of experience, specializing in clinical development for pharma, biotech, medical devices, and consumer health companies, with operations across the Americas, Europe, and Asia-Pacific. Our mission is to contribute to a healthier, safer world by accelerating the development of innovative drugs and devices. We value diversity and inclusivity.

Keywords:

Area Safety Officer, Local Safety Officer, PV, CAPA, Pharmacovigilance