Junior PV Officer at The Biovac Institute

Role Purpose:

The Biovac Institute requires a Junior PV Officer to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.

The successful incumbent will report to RA Manager.

Job Purpose

• Responsible for supporting PV activities at Biovac in order to ensure PV activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements.
• Responsible for monitoring and reporting the effectiveness and any adverse effects or side effects of the Biovac Range of Products on the market and research trials.
• Continuously support and prescribe to cGMP & cGVP within Biovac.
• Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures and other applicable laws.
• Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

Key Duties & Responsibilities

Core Technical Delivery:

• Interviewing, recording and reporting adverse reactions received from healthcare professionals and consumers in accordance to local regulatory requirements within the assigned areas.
• Maintenance of Individual Case Safety Reports including the compilation, filing and scanning of such files.
• Perform post surveillance activities such as literature review and media monitoring.
• Perform reconciliation activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries
• Responsible for maintaining and keeping PV Databases up to date
• Assists and supports department with documentation management.
• Assists with the role out of Adverse Event/Product Quality Complaint Awareness training for the entire Biovac staff.
• Rotational Monitoring of after hour services.
• Assists with preparation for internal and external Audits of Pharmacovigilance.
• Supports the PV team in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented.
• Participates in PV project work when necessary and when deemed appropriate by the RA Manager / PV Officer.
• Completing safety audits

Technical Competencies required to perform this aspect of the role:

• Understanding and working knowledge of regulatory business processes
• Ability to keep meticulous records
• Attention to detail
• Excellent analytical and problem-solving skills
• Ability to interact and communicate effectively with a wide range of people
• A systematic approach to tasks
• Excellent IT skills
• Good interpretative skills
• Teamwork
• Good maths skills
• Other: Fluent in English - verbal and written
• Knowledge of pharmaceutical industry standards and guidelines in GMP / Pharmacovigilance
• Technical Report Writing and attention to detail
• Good working knowledge of Microsoft Office
• Service orientation
• Assertive
• Coaching and mentoring of peers and staff

Quality Management

• Building own, team and site’s GMP Knowledge and Compliance
• Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
• Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
• Maintain a state of control related to quality management within the department
• Ensuring that the department is audit ready through closing out audit findings timeously
• Ensure Deviations, Change Controls, CAPAs are handled effectively
• Advocate continuous improvement within own department as well as cross functionally

Technical Competencies required to perform this aspect of the role:

• cGVP and regulatory compliance knowledge, i.e. SAHPRA, ICH and WHO
• Total Quality Management & Quality Management Systems
• Data development, trending & reporting
• Coaching & mentoring peers & staff

Generic Competencies required to perform this role:

• Planning, Organising, Execution & Delegation
• Strategic & Holistic Thinking
• Creative Problem Solving & Innovation Skills
• Sustainable Stakeholder Management
• Financial Acumen
• Commercial Awareness
• Action & Results Oriented
• Assertive & Resilient
• Adaptable in Responding to change
• Negotiation and influencing skills
• Proactive in mitigating risk
• Clear, timely and effective communication skills both verbally and in writing
• Analytical Ability

Experience & industry accreditation/ knowledge

Required:

• At least 2 years’ experience in pharmacovigilance within the pharmaceutical/ biotech manufacturing industry.
• Experience in quality and regulatory compliance within a cGMP facility.
• At least 2 years’ experience in administration, high degree of computer literacy (MS Office)

Preferred:

• Working Knowledge of Pharmaceutical related legislation
• Experience in having faced successfully local and/ or international quality audits.
• Experience as a CRO

Qualifications

Required:

• Health Care Professional Degree (e.g. Bachelor’s degree in medical science / Nursing Degree or equivalent) or Life Science Degree (e.g. BSc Biology, BSc Pharmacology, BSc Neuroscience)

Preferred

• Bachelor’s degree
• Recognition is given to Prior Learning and practical experience.

Other Requirements

• Own reliable transport