Affiliate Safety Representative

MYLAN s.r.o.

Place of work
Karadžičova 10, Bratislava
Contract type
full-time
Start date
Upon agreement
Basic wage component (gross) and other rewards
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.

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 : [email protected] With CV sent and consent to the processing of your personal data ( the law 122/2013 ) by our company.

Requirements for the employee

Candidates with education suit the position

University education (Master's degree)
Postgraduate (Doctorate)

Language skills

English - Advanced (C1)

Other knowledge

Microsoft Excel - 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

MYLAN s.r.o.
Rožnavska 24
821 04 Bratislava
http://www.mylan.com
ID: 3360450   Dátum zverejnenia: 12.4.2018   Základná zložka mzdy (brutto) a ďalšie odmeny:   Upon agreement