Pharmacovigilance Officer x2 at Aspen Pharma Group

MAIN DUTIES

PHARMACOVIGILANCE SUPPORT

• ICSRs (Individual Case Safety Reports)

1. Performing assessment of adverse event case reports.
2. Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR) and regulatory reporting (RR), in line with current SOPs.
3. The PVO acts as a product owner for products under the remit of Pharmacare, supporting the PV Scientists with literature management and aggregate report preparation.
4. Maintain a high standard of case quality.
5. The PVO is responsible for providing a root cause analysis for any late reporting submissions.
6. Management and prioritization of individual workload while maintaining good documentation practices (GDP).
7. Highlighting any safety related issues to the attention of the management team.
8. Perform pharmacovigilance checks/evaluations of the Quality Assurance database (Trackwise).

• Reconciliation

1. Reconciliation of all adverse event reports received by PV from internal stakeholders (QA/MI and ACC).
2. Reconciliation of all adverse event reports received from PV service providers, affiliates, distributors and license partners monthly; quarterly or bi-annually as described in the Safety Data Exchange Agreement (SDEA).

• Quality Systems Management

1. Support preparation of SOPs, WIs, and product safety reviews
2. Raising of compliance cards for late cases reported to Pharmacare by service providers, affiliates, distributors and license partners.
3. Ensure all allocated CAPAs; Deviations and Actions are closed on time on Trackwise.

• Aggregate Reporting and Regulatory Intelligence

1. Keep abreast of changes to PV Legislation and ensure Regulatory Intel is monitored for ZA and SADC territories.

• Basic PV training for all Aspen employees

1. Contribute to the development of PV training.
2. Pharmacovigilance training of all Aspen employees and distributors/service providers and documentation thereof.

• Literature reviews

1. Regulatory review of key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/medicines.

• Understand SDEA obligations in order to ensure all aspects under agreements are  duly executed.

1. Facilitate SDEA training (to employees as well as 3rd parties).

• Signal management

1. Highlighting any safety related issues to the attention of the management team
2. Co-ordinate Safety Review meetings (monthly)
3. Reviewing of Regulatory websites for any potential signals

• All other ad hoc PV activity duties as required by the business needs
• Adhere to agreed Key Performance Indicators (KPIs).
• Support the continuous development and improvement of the PV function while upholding Aspen core values.
• Receipt, evaluation and reporting of individual case safety reports in accordance with international (export territories) and local regulatory requirements and contractual partner obligations.
• Provide support to Global PV.

CUSTOMER SERVICE

• All queries are followed up and strictly within policy framework i.e. 48 Hours turn-around time.
• A professional attitude is displayed when responding to a customer’s needs.
• Methods for improving customer services are proposed.
• Internal and external customers are kept updated, under supervision, as to the progress of their queries
• Liaise on a daily basis with RA customers, i.e. SAHPRA, Marketing, Manufacturing sites, Quality-related departments, Public Health, Exports, Outsource, and relevant licensors and distributors.

FINANCIAL

• Identification of project challenges to departmental line management and the financial impact thereof

GENERAL

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the PV function while upholding Aspen core values
• Effective management and utilization of resources to keep processes cost effective
• Collating data for ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by your Manager

KNOWLEDGE

• Knowledge of relevant information sources including: printed publications, unpublished sources, databases, websites, social media sites and external bodies.
• Effective understanding and use of the principles of information capture, storage, searching and retrieval.
• Effective use of appropriate IT systems and programs.
• Understanding of relevant legal and related issues on copyright, codes of Practice, Data Protection legislation, regulations and guidelines.

Requirements:

KNOWLEDGE

• Knowledge of relevant information sources including: printed publications, unpublished sources, databases, websites, social media sites and external bodies.
• Effective understanding and use of the principles of information capture, storage, searching and retrieval.
• Effective use of appropriate IT systems and programs.
• Understanding of relevant legal and related issues on copyright, codes of Practice, Data Protection legislation, regulations and guidelines.

SKILLS AND ATTRIBUTES:

• Business process analysis
• Report writing
• Information gathering and monitoring
• Projects (advantage)
• Ability to communicate information effectively and clearly in written form and orally, and at levels appropriate to the needs of different internal and external customers.
• Integrity
• Work ethic
• Ability to meet deadlines
• Positive ‘can – do attitude’
• Work autonomously and have good problem-solving skills
• Able to cope with evolving deadlines effectively with regular feedback and updates
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexible and confidentiality
• Positive and pro-active approach to business tasks
• Enthusiasm and drive to take ownership and drive process initiatives 

EDUCATION & EXPERIENCE: 

• Matric/Grade 12
• Bachelors or Post Graduate degree in science, pharmacy or medicine, or Post Basic Pharmacist Assistant
• PV experience (2 years), experience in post-marketing reporting of AEs.
• Quality Assurance experience (1 year).
• GCP training advantageous.

Closing Date: 12th, July 2022