Compliance manager (pharmaceutical/medical) - Johannesburg
JJOB OVERVIEW:
? Pharmaceutical Marketing Code, policies and procedures and relevant legislation (e.g. Medicines Act 101and Skills Development Act)
? Policies relating to interaction with healthcare professionals and organisations
? Internal SOPs related to departmental management
DUTIES AND RESPONSIBILITIES:
Position Summary:
The Compliance Manager will oversee two compliance aspects : regulatory compliance, especiallypromotional material and ethic compliance for a subsidiary of an international pharmaceutical company.
This role involves ensuring that all aspects of the company's operations adhere to national and internationallaws, industry standards, and corporate policies, particularly those related to drug development, clinicaltrials, marketing, and distribution.
Key Responsibilities:
Regulatory compliance,
o MCA knowledge
o Reviewing of promotional material
o Training and upskilling employees on Compliance parametersEthic compliance
• Policies & processes :
o Develop and implement compliance policies and procedures ensuring alignment to the companies legal framework. i.e purchasing policies
o Ensure the companies adherence to compliance related policies and procedures by developing sustainable Training and guidance on said policies.
o Act as support and first line of defence on all Ethics and Compliance for the business.
• Data integrity
o Ensure data accuracy in maintaining systems and records for audit purposes
o Manage internal and external approval processes
o Maintain accurate, updated paper and electronic files and records for easy retrieval andensure the two systems interface accurately
• Audits
o Conduct regular internal audits to ensure faithfulness to the company policies and SOP’s.
o Manage any external and internal audits around compliance and the management thereof
o Identify compliance gaps and take corrective action to remedy these
o Manage implementation of internal audit recommendations
• Trainings
o Attend and complete the mandated compliance training provided by Head Quarters,
o Monitor business compliance to the control frameworks, escalate issues of non-compliance
and identify and follow-up on training and communication needs
o Provide ongoing training and guidance on relevant compliance matters
o Provide ongoing education to the Sales force on market conduct best practice and risks
o Follow mandatory trainings
• Advisor and compliance responsible
o Become the contact person on all matters relating to Compliance. Serve as an advisor to other department on compliance related queries and questions
o Stay updated with changes in legislation affecting the pharmaceutical industry.
o Collaborate with global teams to align subsidiary compliance practices with overall company standards and to share knowledge and best practice and leverage resources.
o Implement the compliance framework pertaining to interaction with healthcare professionals and organisations
o Ensure those departments that interact with healthcare professionals and organisations understand their key risks, priorities and focus areas from a compliance perspective
o Understand the risks relating to code compliance, internal and external regulations and display proactivity in identifying, mitigating and/or escalating risks to relevant stakeholders promptly
Qualifications:
- Bachelor's degree in Pharmacy, or related field.
- Proven experience in regulatory compliance (promotional materials) within the pharmaceutical industry.
- Strong understanding of South African and international pharmaceutical regulations.
- Excellent communication and interpersonal skills.
- Formal compliance qualification through CISA
The ideal candidate will be a detail-oriented professional with a proactive approach to problem-solving
and a strong ethical standard. The ability to work independently as well as part of a global team is essential.
Fluency in English is advantageous.
• Job Training and Experience:
o Minimum 3 years’ experience in Compliance (Marketing material) – (must have human medicine experience and biologicals)
o Knowledgeable and experience regarding
o In depth knowledge of Regulations, Compliance and Marketing Code of the Pharmaceutical industry
TECHNICAL SKILLS
? Able to analyse, identify and remediate skills and compliance gaps
? Risk assessment and remediation skills
? Able to interpret and advise on the spirit and content of compliance to relevant regulations
BEHAVIOURAL SKILLS
? Able to translate, execute and align strategy
? Highly analytical and attentive to detail with strong big picture thinking and reasoning skills
? Able to build relationships and influence at all organisational levels (internally and externally)
? Able to influence, facilitate and present information in ways enable learning
? Able to identify, co-ordinate and juggle priorities in line with organisational needs
? Able to use the full MS Office suite and learn and apply new system requirements
INDISPENSIBLE QUALITIES:
a) Focus
b) Attention to detail
c) Flexibility
d) Planning and organisation
e) Communication
f) Teamwork
g) Confidentiality
h) Agile and able to work in a fast pac
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