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| Company: |
Medico International Recruitment - MIR |
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| Job Title: |
Pharmacovigilance Officer |
| Job category: |
Pharmaceutical |
| Job Location: |
Mauritius |
| Job Description: |
A Pharmacovigilance Officer is required for a company in Mauritius.
Purpose:
• Ensure effective and accurate collection, database entry, review and reporting of safety data;
• Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products;
• Assist in signal generation and safety analysis activities.
Qualifications & Experience:
• Minimum 2 years experience in the pharmacovigilance field preferably in the EU;
• Science / medical degree;
• Experience with safety databases including simple searches & coding dictionaries ( Clintrace is preferred);
• Knowledge of clinical trial methodology and pharmacovigilance regulations;
• Ability to review, analyze, interpret and present data;
• Good level of computer literacy with Microsoft applications;
• Excellent verbal and written skills – fluency in English essential.
Key Attributes:
• Self starter;
• Problem solving skills;
• Accuracy and attention to detail;
• Effective organization skills and ability to prioritize;
• Ability to work under pressure and to tight deadlines;
• Ability to work in a fast paced international environment;
• Ability to manage projects in a matrixed team environment and with both internal and external partners;
• Willing to travel.
Specific Outcomes / Accountability:
• Negotiate and finalize safety data exchange agreements with affiliates and agents and any other institution where such an agreement is required;
• Ensure compliance of the various parties to the SDEA through desk audits and on site audits where required;
• Set up and formalise the systems that will operate between Aspen XXXX and XXXX
• Co-ordinate all investigations of ADR’s and ensure link with quality function where ADR’s are potentially related to product quality;
• Evaluate safety information and ensure that these are consistent with approved labeling;
• Oversee any clinical or post-marketing surveillance trials;
• Review representative training material from a clinical perspective and ensure compliance with the labeling;
• Attend to the installation and operation and ensure development of a system that could contain the Safety database in time;
• Elevate any significant safety risks within the Group and put forward a risk mitigation strategy;
• Assist the various marketing departments within the global affiliates with medical information and advise;
• Review any new labeling to ensure all clinical parameters are in line with relevant regulation.
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Skills Required:: |
Qualifications & Experience:
• Minimum 2 years experience in the pharmacovigilance field preferably in the EU;
• Science / medical degree;
• Experience with safety databases including simple searches & coding dictionaries ( Clintrace is preferred);
• Knowledge of clinical trial methodology and pharmacovigilance regulations;
• Ability to review, analyze, interpret and present data;
• Good level of computer literacy with Microsoft applications;
• Excellent verbal and written skills – fluency in English essential.
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Language Requirements: |
English-Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
Unspecified |
| Posting Date: |
2009-04-15 |
| Level of Education: |
Unspecified |
| Years of Work Experience: |
No experience |
| Company: |
Medico International Recruitment - MIR |
| Contact Name: |
Medico International Recruitment - MIR |
| Contact Phone: |
04 361 29 25 |
| Preferred Method of Contact: |
No Preference |
| Preferred Language of Resume/Application: |
English |
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