MEDICINES EVALUATOR wanted immediately: APPLY HERE
Ref No.: SAHPRA 009/2020 ((Part-time)
PharmD (Clinical), MBCHB, Clinicians, Clinical Pharmacologist. * At least 8 years post qualification experience. * Detailed knowledge of one or more areas of regulatory activity. * Evaluate novel or complex APIs; peer-review evaluations; mentor lower-level evaluators. Working knowledge of document management and workflow management software is an added bonus as well as the knowledge of CTD and eCTD software applications.
* Knowledge of technical aspects for evaluation of safety and efficacy of medicines. * Sound working knowledge of computer software packages. Ability to: * evaluate scientific evidence of the safety and efficacy of medicines application, * mentor a team of evaluators and develop them from a technical standpoint, * communicate fluently in English with both written and verbal communication.
* Clinical content knowledge of the therapeutic area under evaluation. * Understanding of the pharmacology of the chemical under evaluation. * Understanding of biostatistical principles of medical research. * Able to understand the clinical content knowledge of the therapeutic area under evaluation. * Plans proactively and communicates potential roadblocks to Portfolio Coordinator timeously.
Assess and evaluate the clinical safety and efficacy of applications for the registration of medicines: * Reviews and evaluates the applicant reports relating to preclinical studies submitted in support of the labelling of NCE and generic medicines. * Review of non-clinical data to support labelling of medicines for regulatory purposes. * Consistently update the application manager on the progress of the application. * Prepares a comprehensive summary of the data reviewed and submits an evaluation report regarding the registrability of the application. * Assess the labelling in terms of the assessed data. * Provide input into report results for the technical committee when evaluation result differs to that of the peer reviewer.
* Engages in technical conversations with the applicant should the Portfolio Coordinator deem it necessary. * Other responsibilities as identified by the clinical backlog divisional lead. Technical oversight of the assessment and evaluation of the safety and efficacy of applications for the registration of medicines: * Provide guidance to primary evaluators whilst they conduct reviews. * Reviews primary evaluator’s reports relating to the evaluation of preclinical pharmacological studies submitted in support of NCEs. * Assess product labelling (PI and PIL).
* Consistently update the application manager on applicant information. * Provide input into review results for the technical committee should the review provide a different outcome to that of the primary evaluator. * Provide input into report results for the technical committee. Risk Management and Audit: * Standard operating procedures and guidelines must be adhered to. * Assesses applicant responses to queries on applications for registration of medicines. * Attend relevant training as may be necessary to support your function.
Job Types: Part-time, Contract
8 years: 8 years (Required)
Work Remotely: Yes. Apply Now