Pharmacovigilance Local Contact Person With Hungarian And English Language

2+ years

Not Disclosed

Budapest

10 Nov. 21, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Pharmacovigilance Local Contact Person

Company: IQVIA

Location: Hungary (Fluent Hungarian Required)

Job Overview:
IQVIA is seeking a Pharmacovigilance Local Contact Person to serve as the local Qualified Person for customers requiring pharmacovigilance services for their products. In this role, you will be responsible for managing safety monitoring and regulatory compliance, liaising with competent authorities, and ensuring the accurate evaluation and reporting of risks and benefits for medicinal products.

Key Responsibilities:

Qualified Person: Act as the local Qualified Person in accordance with IQVIA Lifecycle Safety Regulatory Intelligence Database (RID) requirements.
Regulatory Liaison: Be available 24/7 to receive calls from the local Competent Authority and serve as the contact point for pharmacovigilance inspections.
Inspection Support: Deal directly with Competent Authority inspectors during statutory inspections.
Regulatory Compliance: Respond promptly to requests from Competent Authorities regarding the benefits and risks of medicinal products, including post-authorization safety studies.
Safety Monitoring: Stay up to date with local regulatory changes and ensure all safety measures and risk management plans are implemented accordingly.
Project Management: Maintain an understanding of project budgets, scope of work (SOW), and communicate with project managers on updates, customer concerns, and regulatory reports.
Regulatory Reporting: Provide regular updates to the EU QPPV/designee and complete necessary regulatory reports.

Minimum Required Education and Experience:

Education: Bachelor's degree in life sciences, medicine, pharmacy, nursing, or an equivalent field.
Experience: Around 2 years of relevant experience in clinical trial safety or post-marketing safety management, or a combination of equivalent education and experience.
Location: Resident in Hungary with fluent Hungarian language skills (at least C2) and a good command of English (minimum C1).
Regulatory Knowledge: Strong understanding of local, regional, and global pharmacovigilance regulatory requirements, particularly within the EU and Hungary.
Skills: Knowledge of Standard Operating Procedures (SOPs), the ability to assess the benefit/risk balance of products, and familiarity with compliance and quality management systems.
Availability: Must be available 24/7 for Competent Authority enquiries.

About IQVIA:

IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights. Our mission is to accelerate the development and commercialization of medical treatments to improve patient outcomes and population health worldwide.

For more information, visit IQVIA Careers.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji |

Gujarat :

Haryana :

Himachal Pradesh :

Solan |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

PAN-India :

Panjab :

Punjab :

Rajasthan :

Banasthali | Jaipur | Pilani | Udaipur |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Denver |

Connecticut :

Bridgeport | Groton | Storrs |

D.C :

Washington |

Florida :

Georgia :

Atlanta |

Hawaii :

Honolulu |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Lawrence |

Kenlucky :

Shelbyville |

LA :

Monroe | New Orleans |

Maryland :

Baltimore | Elkridge | Gaithersburg | Rockville |

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Minneapolis and St. Paul, Minnesota. |

Missouri :

Fulton | St. Louis |

New Jersey :

New York :

North Carolina :

Concord |

North Caroline :

Ohio :

Cincinnati | Cleveland | Columbus, |

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Nashville |

Texas :

United states :

United States |

United States :

Hawai |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

Bothell | Goldendale | Pullman | Seattle |

WI :

Madison | Wausau |

Wisconsin :

Wyoming :

Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Marburg |

Hessen :

Frankfurt |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

Hubei :

Wuhan |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Pharma Jobs in Argentina & Australia & Canada & Chile & Colombia & Croatia & Egypt & England & Estonia & France & Indonesia & Ireland & Israel & Japan & Korea & Netherland & Portugal & Remote & Saudi Arabia & Spain & Tennessee & Thailand & Turkey

Buenos Aires :

Buenos Aires |

New South Wales :

Sydney |

Queensland :

Queensland |

Republic of Western Australia :

Nedlands |

Canada :

Canada |

Ontario :

North York | Richmond Hill |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Zagreb :

Zagreb |

Republic of Egypt :

Cairo |

United Kingdom :

Harlow | London | Salt Lake City |

Estonia :

Estonia |

France :

Paris |

Jakarta :

Jakarta |

Cork :

Ringaskiddy |

County Dublin :

Swords |

Republic of Ireland :

Dublin | Limerick | Waterford |

Israel :

Tel Aviv | Kfar Saba | Netanya | Be'Er Sheva |

Tokyo :

Otemachi |

Republic of Korea :

Seoul |

Capital of Netherland :

Amsterdam |

Noord Holland :

Haarlem |

Remote :

Switzerland | Remote, USA | Remote - Europe | Remote |

Makkah :

Catalonia :

Barcelona |

Madrid :

Madrid |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Pharmacovigilance Local Contact Person With Hungarian And English Language

Job Description

Key Responsibilities:

Minimum Required Education and Experience:

About IQVIA:

Latest Jobs

Pssm Generative Ai Practitioner

Scientist - Antibody Optimization (Non- Phd)

Senior Scientist, Pkpd Modeling & Simulatio Content Link:N

Senior Scientist, Pkpd Modeling & Simulation

Technical Associate, Animal Care

Associate Scientist (Upstream Process Development)