Pharmacovigilance Officer at Aspen Pharma Group

ROLE PURPOSE:

• To provide support to the Pharmacovigilance (PV) function of the Medical Affairs department in the receipt, assessment, processing and reporting of Individual Case Safety reports (ICSRs) in accordance with PV procedures and PV legislation by ensuring compliance is met to Regulatory bodies, affiliates and partners in the stipulated timelines.

SPECIFIC OUTCOMES / ACCOUNTABILITY:

PHARMACOVIGILANCE SUPPORT

• Performing assessment of adverse event case reports
• 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
• The PVA acts as a product owner for products under the remit of Pharmacare, supporting the PV Scientists with literature management and aggregate report preparation for their assigned products
• Maintain a high standard of case quality
• The PVA is responsible for providing a root cause analysis for any late reporting submissions
• Assisting with reconciliation of all adverse event reports received from PV service providers, affiliates, distributors and licence partners
• Management and prioritisation of individual workload while maintaining good documentation practices (GDP)
• Contribute to the development of PV training
• Support preparation of SOPs, WINS, product safety reviews as required
• Highlighting any safety related issues to the attention of the management team
• Keep abreast of changes to PV
• 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 department 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.
• Pharmacovigilance training of Sales and Marketing personnel and distributors and documentation
• Regulatory review key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/Medicines.
• Perform pharmacovigilance checks of the Quality Assurance database
• Perform monthly or quarterly ADR reconciliation with contractual partners/distributors
• Provide PV Global support when necessary
• Understand SDEA obligations in order to ensure all aspects under agreements are dully

REGULATORY SUPPORT

• Update package inserts as necessitated by changes to the safety information in the Periodic Safety Update reports. Submission to the MCC and follow-up.
• A general PI review of core products and products where molecules are under review. Also continuous review of innovator PI’s in order to ensure update of our generic PI’s in line with
• Initiation and compilation of package inserts of NCE New Product submissions.
• Respond to Clinical Committee Recommendations for New Products and Registered Products
• Support the South African operations in New Product registrations (MCC liaison)
• Update of Summary of Product Characteristics for SSA

MEDICAL INFORMATION

• Reconcile with Medical Information all incoming enquiries.

CUSTOMER SERVICE

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

FINANCIAL

• Project management of contractual and financial aspects of all medical writing projects and translations and the effective utilization of resources to keep processes cost effective
• Identification of project challenges to departmental line management and the financial impact thereof

Requirements

EDUCATION AND EXPERIENCE:

• Bachelors or Post Graduate degree in science, pharmacy or medicine.
• GCP training preferable.
• Medicines Registration Course advantageous
• 3-5 years in a medicine information set up

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

COMPETENCIES: SKILLS:

• 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

COMPETENCIES: ATTRIBUTES:

• 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

ASPEN COMPETENCIES

Business

• Make Good Decisions - Being solution orientated, innovative, agile and proactive. Good decisions are informed decisions
• Accountability/Ownership - employees readily accept responsibility, own decisions and achieve results despite adverse conditions

People

• Communicate Effectively – Informal communications skills. Active listening skills, Writing skills, Presentation skills, meeting facilitation, Empathy
• Leads and influence others – work collaboratively with others to achieve departmental goals

Self

• Continuously Grows & Develops - staying competitive means continually increasing knowledge, skills and capabilities
• Takes action with Integrity - Aspen employees must internalise the principles of the Aspen Code of Conduct and demonstrate integrity, fairness, accountability, respect, transparency and sincerity