Programing Analyst Who Specialized In Computer System Validations, Pharmacovigilance

2+ years

Not Disclosed

Remote

10 Dec. 11, 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 Validation Specialist
Location: Bulgaria, Serbia
Work Schedule: Other
Environmental Conditions: Office

Job Description:

Join Thermo Fisher Scientific and make a meaningful impact on a global scale. Every day, our team brings our mission to life by enabling customers to create a healthier, cleaner, and safer world. We provide our global teams with the resources they need to achieve individual career goals while advancing science to address some of the world's toughest challenges, including environmental protection, food safety, and finding cures for cancer.

Location/Division Specific Information:

Location: Bulgaria, Serbia
Division: Pharmacovigilance

Key Responsibilities:

Assess and define validation projects for assigned systems.
Write, review, and implement validation protocols for standard and customized systems.
Validate Pharmacovigilance (PV) systems.
Identify discrepancies and address issues during the closeout of test documentation.
Collaborate with internal teams and vendors in case of any Operational Qualification (OQ) failures and prepare evidence for team meetings.
Conduct deviation investigations, such as validation failures and complaints, and identify corrective actions.
Resolve technical issues related to PV systems.
Work closely with IT and QA departments to ensure seamless system performance.
Communicate effectively with both internal and external clients.

Education:

Bachelor’s degree or equivalent combinations of education, training, and relevant work experience will be considered.

Experience:

Minimum of 2 years of experience in Patient Safety Computer Systems implementation, preferably within the biotech or pharmaceutical sector.
Experience with Argus, Gateways, and other PV systems AI platforms.
Self-motivated and proactive with strong time-management skills.

Knowledge, Skills, and Abilities:

Solid understanding of regulatory standards and SOPs.
Experience with Computer Systems Validation (CSV), including execution of OQ and PQ.
Attention to detail and ability to identify and address issues found during testing.
Strong verbal and written communication skills, with the ability to create technical documentation.
Proficiency in Microsoft Office, especially Word and Excel.

About Us:

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. With over 100,000 colleagues, we share a common set of values: Integrity, Intensity, Innovation, and Involvement. Together, we accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Denver |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | United States |

United States :

Hawai | Sylmar |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Latvia | Leuven | Poland | Spain |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Australia

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Richmond Hill | Uxbridge | North York | Mississauga |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Athens | Koropi |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

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

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Programing Analyst Who Specialized In Computer System Validations, Pharmacovigilance

Job Description

Job Description:

Location/Division Specific Information:

Key Responsibilities:

Education:

Experience:

Knowledge, Skills, and Abilities:

About Us:

Latest Jobs

Medical Coder

Hospital Pharmacist

Principal Statistical Programmer

Senior Principal Biostatistician

Associate Director - Pks Drug Disposition, Hyd

Tco Physician

Director - Pks Gh Ta Lead

Medical Director Ii

Clinical Operations Specialist

Analyst, Global Stability