EU Qualified Person for Pharmacovigilance

hameln rds s. r. o.

Place of work
Horná 36, Modra
Contract type
full-time
Wage (gross)
From 1.300,- € Commensurate with experience

Information about the position

Job description, responsibilities and duties

Description and responsibilities:
We are looking for an experienced person to deliver the specific duties of the EU Qualified Person for Pharmacovigilance (EU QPPV) and to maintain oversight of the EU element of the established hameln Pharmacovigilance system.

The role will involve an understanding of the following systems and processes:
• Pharmacovigilance System Master File (PSMF):
• Quality Management Systems:
Maintenance of the PV Quality Management System and associated quality‐ related activities including Audit, Compliance Monitoring including implementation of CAPAs and Quality Improvement. Participation in audits and inspections.
• Safety Data Management:
Processing and Maintenance of cumulative safety data received from all sources including spontaneous reports, literature sources, National Regulatory Authorities and the EMA.
• Signal Management; Risk Management and Minimisation:
• EudraVigilance:
Management of case data, signal detection activities on the EudraVigilance dataset, maintenance of product information and administration of company accounts.
• Product labelling:
Updates to product labelling (SmPC, PIL, packaging) and oversight of associated regulatory activities.
• Communication:
With the EMA and other EU health authorities.

Employee perks, benefits

• As an experienced pharmaceutical professional this is an excellent opportunity for you to develop and broaden your skills in this important role within our well established Pharmacovigilance System.
• As EU QPPV you will report directly to the Head of Medical Affairs hameln and will have the full support of the Medical Affairs team.
• There will be a full initial training programme and continuing support for ongoing professional development.
• You will be based in Slovakia with travel to company offices in the UK and Germany as required.

Information about the selection process

Ďakujeme všetkým záujemcom. Vyhradzujeme si právo kontaktovať uchádzačov vhodných na inzerovanú pracovnú ponuku.

Zaslaním Vášho životopisu zároveň dávate súhlas so spracovaním Vašich osobných údajov uvedených v životopise za účelom výberu uchádzačov v zmysle Zákona č. 122/2013 Z.z. o ochrane osobných údajov.

Requirements for the employee

Candidates with education suit the position

University education (Master's degree)

Educational Specialization

A degree in Pharmacy or an additional postgraduate degree would be an advantage.

Language skills

English - Advanced (C1)

Other knowledge

Microsoft Excel - Advanced
Microsoft Windows - Advanced

Driving licence

B

Number of years of experience

5

Personality requirements and skills

• 5 years of relevant (post-marketing) EU Pharmacovigilance experience.
• Excellent communication skills, in both the Slovak and English languages.
• The ability to work across hameln sites to build and maintain effective working relationships with cross-functional and multi-national colleagues.
• Professionalism and integrity.

Advertiser

Brief description of the company

We, hameln rds s.r.o., located in Modra, Slovakia are part of the Hameln group, an internationally operating group of pharmaceutical companies with an European headquarters and a long-term corporate strategy. The main focuses are the development and the production of Active Pharmaceutical Ingredients (APIs) for sterile injectable pharmaceutical products and of all relevant services to market a pharmaceutical product (e.g. Stability testing, market release analysis, galenical development).

Number of employees

100-149 employees

Contact

Contact person: Ľudmila Lattová
E-mail: send CV
ID: 3670073  Dátum zverejnenia: 16.5.2019  Základná zložka mzdy (brutto) a ďalšie odmeny: From 1.300,- € Commensurate with experience