Compliance Specialist 37 views
Job Overview
- Salary Offer Market Related
- Experience Level Junior
- Total Years Experience 0-5
Purpose:
A multinational pharmaceutical company is seeking a Compliance Specialist who will be responsible for:
- Ensuring the implementation and monitoring of the Regional Compliance programme
- Play a pivotal role in ensuring adherence to legal, integrity, and company compliance standards across the Africa region
- Provide guidance on legislative compliance matters, assist in the implementation of an effective compliance programme, and support the organisation in fostering a culture of integrity and accountability
Key Job Outputs:
Legislative compliance
- Ensure company operations adhere to applicable Global company policies, local and international pharmaceutical laws, regulations, and industry codes (e.g., South African Marketing Code Authority, Protection of Personal Information Act, and other relevant African country regulations)
- Stay updated on legislative developments in the Africa region that impact pharmaceutical compliance and provide recommendations for implementation
- Ensure that all compliance elements are effectively implemented and adhered to
- Forwarding of all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs
- Ensure the availability of training plans according to the direct reports’ role profiles within the team
- Ensure that the relevant training has been completed according to the training plan
Compliance programme development
- Implement and maintain compliance policies and procedures in the region to ensure alignment with corporate standards and regulatory requirements
- Develop region-specific Standard Operating Procedures (SOPs) and guidelines tailored to individual markets
- Lead with the Head of Compliance, the preparation for and management of internal and external audits, ensuring readiness and regulatory alignment
Training and awareness
- Deliver under the guidance of the Head of Compliance, training programmes to employees and business partners on compliance topics, including anti-bribery, anti-corruption, privacy regulations, and ethical marketing practices
- Promote a culture of compliance through regular communication and engagement initiatives
Risk assessment and mitigation
- Conduct periodic compliance risk assessments and implement mitigation strategies in accordance with the Global Compliance Monitoring Programme
- Investigate compliance concerns, manage corrective action plans, and escalate issues when necessary
- Monitor high-risk areas such as promotional activities, interactions with healthcare professionals, educational grants, sponsorships and patient support programmes
Cross-functional collaboration
- Partner with internal stakeholders, including sales, marketing, legal, and regulatory affairs, to ensure compliance integration into all business activities
- Support compliance needs for cross-border operations and provide advisory services on market-specific requirements
- Collaborate with Global Compliance teams to align Regional activities with corporate strategy
Reporting and monitoring
- Maintain a robust reporting framework for compliance activities, including metrics for effectiveness and accountability
- Prepare reports on compliance trends, activities, and issues for submission to the Head of Compliance
- Oversee third-party compliance due diligence and monitoring
Core Competencies:
- Strong communication, training, and stakeholder management skills
- Analytical thinking with attention to detail and a proactive mindset
- Integrity and sound ethical judgement
- Ability to navigate and manage complex regulatory environments
- Strong interpersonal skills with a collaborative approach
- Capacity to handle multiple priorities in a fast-paced, dynamic environment
Qualifications:
- Bachelor’s degree in Law, Compliance, Business, Pharmacy or a related field
- Advanced degrees (e.g., LLB or MBA) are advantageous
Experience:
- Minimum 3-5 years of compliance experience within a multi-national pharmaceutical company, preferably servicing the Africa region
- Strong knowledge of pharmaceutical and health regulations in South Africa and other African countries
- Experience in implementing and managing compliance programmes and investigations
- In-depth understanding of industry codes (e.g. IFPMA, EFPIA, SA Marketing Code, SAMED Code etc.)
- Familiarity with privacy regulations, including POPIA and GDPR
Salary: Market related
Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.
All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013
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