QA / QP PV Officer

hameln rds a.s.

Place of work
Horná 36, Modra
Contract type
full-time

Information about the position

Job description, responsibilities and duties

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 and to maintain QA Management system.
The main responsibilities:
• Pharmacovigilance System Master File (PSMF):
Maintenance of the Pharmacovigilance System and 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.
• 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.

Basic wage component (gross) and other rewards

from 1.300,- €

Employee perks, benefits

• Extensive training
• Self-reliant and responsible work
• Participation in a dedicated team
• Exciting tasks
• Growing company
• Flexible working hours

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

Pharmacy, Medicine, Natural Sciences, or comparable education

Language skills

English - Advanced (C1)

Other knowledge

Microsoft Excel - advanced
Microsoft Word - advanced
Microsoft Outlook - advanced

Driving licence

B

Number of years of experience

2

Personality requirements and skills

• At least 2 - 3 years’ experience in the
Pharmacovigilance
• Fluent in written and spoken English
• Written and spoken German is of advantage
• Precision and independence
• Ability to work in team
• Ability to work under pressure
• Personal creative thinking
• Good Communication Skills

Advertiser

Brief description of the company

Hameln rds offers services needed in bringing a pharmaceutical product into the market from a single source. With about 100 employees, we work with national and international customers from the pharmaceutical, biotechnological, chemical and medical technology industries.

For this purpose, we offer a complete value chain which is unique on the international healthcare market: from product development and laboratory services, preclinical studies, a full registration service including the handling of all issues related to existing registrations, through to the reliable supply of APIs and finished products including the necessary EU market approvals.

Number of employees

100-149 employees

Company address

hameln rds a.s.
Horná 36
900 01 Modra
http://www.hameln-rds.sk

Contact

Contact person: Ľudmila Šaturová
E-mail: send CV
ID: 3670073   Dátum zverejnenia: 16.5.2019   Základná zložka mzdy (brutto) a ďalšie odmeny:   from 1.300,- €