Patient Safety Officer, Russia/ Специалист по фармаконадзору, РоссияApply NowEmail Me Job ID R0022605 Date posted 10/22/2020 Location: Moscow, Russia
Education background and key skills:
- Medical university background;
- Fluent English (at least upper intermediate level);
- Accuracy, attentiveness, ability to perform monotonous and overtime work, experience in office work with documents, databases, desire and ability for learning;
- Experience in a foreign pharmaceutical company (Pharmacovigilance) is desirable.
Key PV Specialist Responsibilities
· Receive and process the adverse event, SSR information from solicited and spontaneous reports, literature sources per applicable standard operating procedures.
· Receive and initially process Product Complaints, Medical Information requests and forward the relevant information to the appropriate Quality Assurance and Medical Affair staff.
· Manage local medical literature surveillance in accordance with local and Global SOPs.
· Ensure data accuracy, regulatory reporting status assessment, and follow-up is completed on pharmacovigilance cases.
· Report the appropriate ICSR/SSRs to Global PV and local Regulatory Authorities according to applicable regulation and standard operating procedures.
· Maintain a log, compliance information and filing system for all relevant ICSR/SSRs according to applicable standard operating procedures.
· Provide and document pharmacovigilance trainings to internal staff, and external partners, as required.
· Maintain oversight of Market Research (MR) and/or Patient Support Programs (PSPs), initiated sponsored research (IISR), non-interventional studies, compassionate use, named patient supply, company sponsored web-sites and digital media open to User Generated Content (UGC) conducted at the LOC to ensure safety information is managed appropriately.
oCompetitive salary and bonus system
oMedical and life insurance
oMeal and phone allowance
oCorporate car and iPad
oPreferential programs for employees
oCorporate events and celebrations
oAbility to learn from the best-in-class colleagues
oUnlimited opportunities for professional self-realization
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