Clinical Pharmacist Woodmead (Salary R40K to R45K pm) CLOSING DATE 18 March 2013 Applications are invited for the above-indicated vacancy that exists in the Medical Affairs. The incumbent will report directly to: Executive: Group Safety and Pharmacovigilance ROLE PURPOSE: Medical review of the clinical component of advertorial, marketing material and training material. Pharmacovigilance responsibilities for local and export market. Compile/update and submit PIs to MCC where necessitated by changes to PSUR safety information and new safety issues. Compilation of detailed clinical recommendations or clinical components of New Product submissions (NCEs) and also include PI initiation. Medical Information. Support in maintaining database for PI. Regularly review key Medical Journals for any adverse drug reaction reports with products/medicines. Key Responsibilities: FINANCIAL: • Effective utilization of resources to keep processes cost effective CUSTOMER SERVICE: • All queries are followed up and resolved in the shortest possible timeframe within policy framework • A professional attitude is displayed when responding to a customer’s needs. • Methods for improving customer services are proposed, developed and continuously updated. • Internal and external customers are constantly updated as to the progress of their queries CLINICAL REVIEW OF ADVERTORIAL AND MARKETING MATERIAL: • Review and approval of advertorial ,marketing and training material for medical accuracy and clinical content to ensure compliance with the Marketing Code and ASA standards, where required. • Provide ongoing support and education to the product managers with regard to clinical content of advertorial. • Proactive and ongoing assessment of clinical issues on key products. Initiation of discussion and activity on products with clinical issues affecting sales. • Support training managers in compiling the training material used for Sales representatives for all Pharmacare products REGULATORY SUPPORT: • Compilation of detailed clinical recommendations or clinical and pre-clinical components of NCE New Product submissions. • Respond to all Clinical matters as raised by MCC on NCE and registered products • 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 these. • Initiation and compilation of package inserts of NCE New product submissions. • Support the South African operations in New Product registrations (MCC liaison) - PHARMACOVIGILANCE: • 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 documentation thereof. • Regularly review key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/medicines. • Preparation and approval of all Periodic Safety Update Reports required for regulatory submission and license renewal as required EDUCATION: • B.Pharm degree • Postgraduate tertiary degree in Clinical Pharmacology EXPERIENCE: • Clinical Pharmacology knowledge essential • 2 years experience in Pharmacovigilance arena • Clinical Epidemiology knowledge an advantage • Computer Literate – MS Office COMPETENCIES: Skills: • Judgement, Influencing, Time management, Problem solving, Analytical skills, Listening skills, Service Orientation, Decision making skills, Computer literacy, Written and verbal communication skills Attributes • Customer focussed, Attention to detail, Influence, Tenacity, Accuracy, Initiative, Logical thinking Information seeking, Enquiring Mind, Patience Please mail Cv’s to carolinem@godisanang
Posted on: Fri, 14 Mar 2014 13:19:11 +0000