Affiliate Safety Representative
MYLAN s.r.o.
Place of work
Karadžičova 10, Bratislava
Karadžičova 10, Bratislava
Contract type
full-time
full-time
Start date
Upon agreement
Upon agreement
Basic wage component (gross) and other rewards
Upon agreement
Upon agreement
Information about the position
Job description, responsibilities and duties
The Affiliate Safety Representative (ASR) is responsible to organize, implement, and maintain the Affiliate PV System. Ensures local processes and procedures are in place to define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations.
• Maintains a version-controlled training matrix. Ensures training of affiliate personnel and partner company staff is undertaken according to relevant SOPs, and that appropriate training records are maintained.
• Collection and reporting PV-relevant information and ICSRs in accordance with global and local procedures, reconciliation of PV-relevant information with Global PSRM, affiliate non-PV functions, commercial partners and service providers. Timely identification and appropriate response to incidences of noncompliance.
• Local implementation and tracking of activities in accordance with Risk Management Plans (RMPs).
• Ensures local language medical or scientific literature, not included in PSRM global literature review, are reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV and local competent authority (as required).
• Archiving of local PV documents and maintain business continuity management for critical PV processes.
• Maintains awareness of local PV legislation. Ensures PSRM is notified of any important changes to relevant Local Legislation.
• Ensure the content of local pharmacovigilance agreements conforms to Mylan standards and local requirements.
• Maintains a version-controlled training matrix. Ensures training of affiliate personnel and partner company staff is undertaken according to relevant SOPs, and that appropriate training records are maintained.
• Collection and reporting PV-relevant information and ICSRs in accordance with global and local procedures, reconciliation of PV-relevant information with Global PSRM, affiliate non-PV functions, commercial partners and service providers. Timely identification and appropriate response to incidences of noncompliance.
• Local implementation and tracking of activities in accordance with Risk Management Plans (RMPs).
• Ensures local language medical or scientific literature, not included in PSRM global literature review, are reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV and local competent authority (as required).
• Archiving of local PV documents and maintain business continuity management for critical PV processes.
• Maintains awareness of local PV legislation. Ensures PSRM is notified of any important changes to relevant Local Legislation.
• Ensure the content of local pharmacovigilance agreements conforms to Mylan standards and local requirements.
Employee perks, benefits
Ever growing team with lots of perspective and potentional for the future
Information about the selection process
If you are interested please send your CV to e-mail : katarina.lieskovska@mylan.com. With CV sent and consent to the processing of your personal data ( the law 122/2013 ) by our company.Expected date of completion of the selection process
1 May 2018 (ostávajú ešte 7 dni)
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Language skills
English - Advanced (C1)
Other knowledge
Microsoft Excel - advanced
Microsoft Word - advanced
Microsoft Outlook - advanced
Microsoft PowerPoint - advanced
Microsoft Word - advanced
Microsoft Outlook - advanced
Microsoft PowerPoint - advanced
Driving licence
B
Number of years of experience
2
Personality requirements and skills
Flexibility, Creativity, Independence, Communicability
Advertiser
Brief description of the company
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you. If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care. Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer.
Number of employees
50-99 employees
Company address
Contact
ID: 3360450 Dátum zverejnenia: 12.4.2018 Lokalita: Bratislava Pozícia: Drug Safety Specialist Spoločnosť: MYLAN s.r.o. Základná zložka mzdy (brutto) a ďalšie odmeny: Upon agreement