| Date | 2024-07-07 |
|---|---|
| Job Title | Compliance Manager (Pharmaceutical/Medical) |
| Employer | Curiska More Information |
| Salary | 0 |
| Category | Medical |
| Location |
Gauteng / Johannesburg |
Job Summary
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 SOPs.
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
Compliance Manager (Pharmaceutical/Medical) position available in Gauteng, Johannesburg. This job position was posted by Curiska. The job has been posted as a premium ad on 2024-07-07 at 13:06:29 in the Medical category
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