JOB DESCRIPTION
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FMD K&L Europe is seeking an enthusiastic candidate with medical background to fill the position of Pharmacovigilance Scientist within Pharmacovigilance Department. The basic function is to support different pharmacovigilance activities upon client request. All the candidates will be initially trained and supervised by their team leads for the first period of recruitment to be ready to start to work with a client.
RESPONSIBILITIES
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Product Literature Reviews
- Perform routine Literature Review for detection of safety signals;
- Perform ad hoc comprehensive Literature Review for designated safety signal as requested;
- Review, analyze and develop conclusions based on sound scientific and medical knowledge and with reference to the existing product label;
- Provide a summary report of the review to the relevant SRL.
Case/ Case Series Reviews
- Review, analyze, synthesize Individual Case Safety Report (ICSR) and narrative line listing data, and/ or develop conclusions relative to:
a) Risk Management Plans (RMPs);
b) Scheduled Reports/Safety Updates (i.e. PSURs/PBRERs, DSURs).
Ad-hoc Requests/ Reports
- Post-submit Advisory Committee briefings.
Labeling Updates
- Review the AE data relative to a potential manufacturing deviation;
- Aggregate data reviews;
- Support signal evaluation and data review;
- Review safety database, including a detailed review of relevant individual records in support of signal evaluation;
- Search and summarize the background information required for signal evaluation from internal and external domain e.g. history of the issue, label, registration status, class effect, epidemiology data knowledge of disease;
- Prepare a summary slide stating outcome of routine literature;
- Where appropriate, prepare slides highlighting key aspects of relevant literature articles as related to potential signals;
- Prepare slides summarizing details of individual record report narratives with highlighted aspects relevant to potential signals;
- Prepare a summary slide stating whether as a result of review a signal has been detected and what the recommended action will be.
REQUIRED QUALIFICATIONS
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- Higher medical degree (Medical Doctor or Dentist);
- At least 2 years of clinical work experience;
- English skills, including excellent reading and writing skills, advanced speaking skills;
- Ability to work full-time;
- Attention to details;
- Ability to multi-task;
- Knowledge of pharmacovigilance field and research is a plus.
APPLICATION PROCEDURES
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Interested candidates are welcome to send their CV to:
arm.hr@klserv.com indicating the position title ("Pharmacovigilance Scientist") in the subject line of the email. The Company appreciates all the interested candidates, however only the shortlisted candidates will be contacted for the upcoming interviews.
Please clearly mention in your application letter that you learned of this job opportunity through Career Center and mention the URL of its website - www.careercenter.am, Thanks.