Pharmacovigilance (PV) Specialist

Typ práce: hlavní pracovní poměr

For prestigious biotechnological company in Prague I am searching for pharmacovigilance specialist. 

Qualification/background: 

• Advanced degree in healthcare related field (MD, PharmDr, Life Science) 
• Experience with product safety/PV in biopharmaceutical industry (including CA, CRO, BioPharma) in clinical development (at least 2 years)

Responsibility/key activities:

• PV system
• Product safety management (including the collection, processing, reporting of AEs) 
• Compliance with external regulation of PV/product safety in Europe, USA 
•  Readiness for PV audits and inspections 
•  Involvement with PV audits and inspections 
•  Liaising with external parties 
•  PV vendor management (including PV Safety dB) 
•  PV risk assessment and risk minimization 
•  PV/product safety training and education 
•  PV/product safety SOPs and WIs 
•  SAE management in efficient, time-sensitive and regulatory compliant manner 
•  PV budget 
•  Review and submission of aggregate reports (safety data)
• Skills/knowledge/competences 
• Working knowledge of Czech and international (EU,US) product safety/PV regulatory environment 
•  Fluent English – spoken and written 
•  Ability and willingness to learn 
•  Communication skills 
•  Time management 
•  ICT (MS Office, IN)

Organizational: Reporting to Head of PV

Scope: Czech Republic, Europe, USA

Offer:

• Support by the expanding and strong company 
• Very motivating salary and an above standard package of employee benefits 
• Professional colleagues and working environment

Start date: upon agreement

In sending your CV you give your consent to processing and holding of your personal data in accordance to Act. No. 101/2000 Coll. regarding personal data protection by LN Human Resources s.r.o., ID: 24275336 until a written form revocation. Your personal data can be provided to third persons in order to obtain employment, namely after prior approval.

Kontaktní osoba:
Ing. Lada Neškrábalová, MBA

E-mail:
lada.neskrabalova@LNHR.eu

Telefon:
722 950 102

Vloženo: 14.10.2014