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Division
Quality Assurance
Department
Drug Safety
Employment Type
Permanent
Job Purpose
Manage and ensure that the Company is at all times, compliant with the relevant laws, regulations and guidelines that govern drug safety and for establishing and maintaining the drug safety system so that information regarding all suspected adverse reactions reported to Company employees, are collected and collated in order to be accessible to get an overall view.
Accountabilities-1
1. Drug Safety
Oversee and direct the drug safety activities and essential related tasks for the Company. This involves, but is not limited to oversight of the following areas:
- Establish and maintain a system which ensures that information about all suspected adverse reactions, which are reported to the company or organisation, including to medical representatives and clinical research associates, is collected and collated so that it is accessible at a single point.
- Collection, evaluation, processing and submission of Individual Case Safety Reports (ICSR’s).
- Preparation and submission of Periodic Safety Update Reports (PSUR’s), when necessary.
- Risk Management Plans (RMP’s).
- Negotiation, implementation and maintenance of Safety Data Exchange Agreements.
- Implementation and maintenance of Drug Safety System Database and Master Files and reconciliation of drug safety data.
- Conduct reconciliation with 3rd parties where required.
- Conduct literature searches as required by legislation.
- Respond to the SAHPRA and/or NADMC on safety queries related to Company products.
- Provide input to annual product quality reviews (APQR’s) where appropriate.
- Training of Company employees on the relevant drug safety procedures.
- Ensure drug safety compliance with relevant legislation appropriate for each jurisdiction in which Cipla Medpro markets products.
- Ensure that all drug safety processes and procedures are consistent and appropriate and that all Company staff are trained on the relevant procedures.
Accountabilities-2, 3 and 4
2. Develops and Manages External Stakeholder Relationships
- Identifies and develops key relationships with Business Partners
- Complies with the requirements set out in the PVA/SDEA’s
3. Develops and Manages Stakeholder Relationships
- Identifies and develops key relationships with Cipla global
- Leverage compliance expertise and alignment with Global Drug Safety
- Maintains a high profile with regulatory authorities, industry bodies etc. in order to positively influence perceptions of the company and its aims.
4. Cross‐Functional Alignment
- Determines how function can service the business optimally
- Measures stakeholder satisfaction and performance and means to improve performance
- Adherence to SLA's and performance criteria
Accountabilities-5
5. People Management
- The hiring of appropriately skilled personnel in line with Cipla Medpro’s transformation objectives, competence verification, HR record keeping and organogram maintenance.
- Ensuring the provision of training for the DS team and the assessment of the effectiveness.
- Ensuring the provision of appropriate PV induction training to all new Cipla Medpro employees by a member of the DS team.
- Ensuring that DS team members have up to date Job Descriptions (JD) by performing an annual review or when scope of work changes
- Ensuring that DS team members have SMART objectives set for DNA purposes.
- Ensuring that DS team members receive ongoing training and facilitate career development interventions.
- Together with the VP: Head of Quality, assess and manage the DS team members’ performance as stipulated in their respective JD’s and DNA objectives.
- Ensures that HR Policies are adhered to by Quality Operations team members and intervene as required when these are breached.
Education Qualification
University graduate of a science degree or Masters in a medically related discipline.
Relevant Work Experience and Skills
- Minimum 5 years’ pharmacovigilance role covering all areas of the function.
- Pharmacovigilance and/or regulatory experience (min. 5 years) with exposure to and knowledge of PV requirements in South Africa and Africa.
- Soft Skills: Information management and organisational skills- Effective understanding and use of the principles of information capture, storage, searching and retrieval.
- Effective use of appropriate IT systems and programs.
- Acute Attention to detail
- Analytical skills- Ability to analyse and appraise safety data as part of the ongoing benefit-risk assessment of the company’s products.
- Communication skills
- Insight into legal and compliance
- Accountability
- Proactivity
Competencies/Skills
Job Location
Cn be based either Johannesburg (Midrand) or Cape Town (Head Office - Bellville)
EE Requirement
Cipla is an Employment Equity employer and this position will be filled based on our Employment Equity Plan.
