Posted - 1/01/2012
Pharmacovigilance Specialist
Job details:
Представительство фармацевтической компании в Украине объявляет конкурс на вакантную должность:
Pharmacovigilance Specialist
Alcon, a Novartis company, is the global leader in eye care with an unparalleled width of product offerings in surgical, pharmaceutical and vision care. Our broad range of products represents the strongest portfolio in the eye care industry. Currently, our products are sold in over 180 countries, and we are present in most markets where eye care professionals practice.
Major Activities
- Complaint reports handling for Drugs and Medical Devices (safety and quality related);
- Arrangement of pharmacovigilance trainings for staff and distributors;
- Providing information to respond to customer queries;
- Periodic safety update report handling;
- Labeling updated for medical devices;
- Labeling variations for drugs (safety related);
- Ensuring the compliance of Ukrainian Drugs Inserts with English Summery product characteristics;
- Handling of safety issues during drug renewal process;
- Maintenance of documentation and procedures related to postmarketing vigilance;
- Participation in vigilance audits, inspections;
- Handling of other safety/quality related activities including communications with Alcon Medical Safety/Quality assurance and pharmacovigilance department of Ukrainian Regulatory Body/State Drug Quality Control Inspection; medical sites visit in case of need;
- Monitoring and implementation of all regulatory changes concerning pharmacovigilance;
- Assistance in registration of drugs and MD in case of need.
Requirements to candidate:
- Graduate in medicine or pharmacy;
- At least 2 year experience in the pharmaceutical industry;
- Fluent in both written and spoken English;
- Excellent communications and negotiations skills
- Quality and focus oriented
- Good computer skills
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