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Pv Country Lead

5+ years
Not Disclosed
10 April 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: PV Country Lead

Location: Prague, Czechia (Additional locations: Bratislava, Slovakia)
Job Type: Full-Time
Job Level: Senior
Travel: Minimal (if any)


Overview:
Takeda, a company that has been at the forefront of innovative therapies for over 240 years, is looking for passionate individuals to join their global team. The company prides itself on its collaborative environment, where every voice matters and new ideas are encouraged. With a strong legacy of trust and science, Takeda continues to transform patient care worldwide.


Job ID: R0149786
Date Posted: 04/23/2025

By clicking the "Apply" button, you acknowledge that your employment application process with Takeda will commence and your information will be processed in accordance with Takeda’s privacy policies. All information you provide must be true to the best of your knowledge.


Job Description

Role Objective:

  • Manage the Pharmacovigilance (PV) relationship within the local operating companies in the Czech Republic and Slovakia.

  • Act as the Local/National Contact Person for Pharmacovigilance (LCCPV) in both countries.

  • Maintain an efficient PV system in compliance with national regulations and pharmacovigilance procedures.

  • Provide PV expertise and support across country operations within the cluster.

Key Accountabilities:

  • Act as appointed LCCPV in Czech Republic and Slovakia, meeting all local regulatory requirements.

  • Oversee the PV system, ensuring compliance with global, regional, and local legislation, and managing PV processes, quality, and business continuity.

  • Collaborate with internal and external stakeholders to implement PV strategies and ensure oversight.

  • Maintain a stakeholder network to facilitate PV operations and act as a subject matter expert on regulatory requirements and compliance.

  • Identify gaps and quality events, initiate CAPA development, and support PV audits and inspections.

  • Collaborate with other PV personnel and support local companies within the cluster as needed.

  • Embrace Takeda’s cultural mindset of “Patient, Trust, Reputation, and Business” to deliver on team goals.

Education, Experience, and Skills:

  • Meets all local requirements for Contact Person for PV in Czech Republic and Slovakia, including education, language proficiency, and experience.

  • Health professional or life sciences degree (Bachelor’s required; advanced degree preferred).

  • Minimum of 5 years of advanced experience in PV or related environments.

  • Strong knowledge of PV regulations and guidelines for the post-marketing environment, including local requirements.

  • Excellent communication skills in local languages and English, with experience working within virtual teams.

  • Collaborative, flexible mindset with cross-cultural awareness.

  • Strong organizational skills with the ability to prioritize under pressure.

  • Proficient in documentation practices with attention to detail.

  • High standard of computer literacy.


Compensation and Benefits:

Takeda offers a competitive compensation package, including a comprehensive benefits program.


Locations:

  • Prague, Czech Republic

  • Bratislava, Slovakia

Worker Type:
Employee

Worker Sub-Type:
Regular

Time Type:
Full-time