Local Drug Safety Specialist / PV Specialist

Naším klientem je významná zahraniční farmaceutická společnost, která má v portfoliu originální i generické produkty. V rámci změn v týmu hledáme nové kolegy do SALES:

Local Drug Safety Specialist / PV Specialist

The primary role is to support local affiliate activities within the scope of EU PV guidelines and company SOPs and directives.

Your responsibilities:

• Responsibility for full-scope company PV agenda in line with EU and interna directives.
• Audits and CAPA management from state authorities and internal audits
• Drug safety evaluation during post-authorization period
• Literature monitoring, translation of relevant cases and medical data
• AE reporting and follow-up
• Participation in case management process
• External reconciliation with 3rd parties, patient registries
• Internal reconciliation with Quality and Medical team
• Participation in routine Pharmacovigilance activities such as conducting ad-hoc and annual internal company trainings
• Risk Management Plans – implementation, monitoring, communication with marketing team and state authorities.
• Creation and management of local SOPs
• Support to regulatory department in preparation and management of safety variations if needed

OUR CLIENT´S REQUIREMENTS:

• University degree – Medical Doctor or Doctor of Pharmacy
• Previous experience in PV 2–3 years is a must
• Advanced level of English
• Excellent communication and organization skills
• Willingness and desire to learn new things
• Detail oriented, hardworking personality
• Team player

BENEFITS AND MOTIVATION:

• Challenging career opportunity to work for a successful international company with wide range of medicinal products
• Opportunity to broaden your knowledge and expertise in your field of PV
• Possibilities for own personal growth and further language development
• Competitive remuneration
• Wide portfolio of employee benefits
• Above-standard social, healthcare and educational program
• Start in May of June 2020