Pharmacovigilance Reporting Associate

0-2 years

Not Disclosed

Remote, USA

10 Nov. 8, 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

About ICON plc

ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to shaping the future of clinical development. We foster a culture of innovation and excellence, creating an inclusive environment where all team members can thrive. Join us in our mission to improve healthcare outcomes worldwide.

Role Overview

We are seeking a Pharmacovigilance Reporting Associate to join our team at the ICON Taipei office. In this role, you will support the accurate and timely reporting of safety information related to clinical trials and pharmacovigilance activities. You will ensure compliance with regulatory requirements, client expectations, and ICON standards.

Key Responsibilities

Safety Reporting:
- Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety information to clients, regulatory authorities, ethics committees, investigators, and third-party vendors.
- Release safety reporting intelligence for expedited and periodic reports in accordance with company procedures and timelines.
- Ensure that all safety reports are submitted within specified timelines in compliance with project requirements.
Project Oversight:
- Monitor project timelines and ensure ICON, sponsor, and regulatory deadlines are met for safety reporting activities.
- Take ownership and accountability for safety reporting activities on assigned projects, ensuring accuracy and timeliness in line with ICON standards and client expectations.
- Operate in a lead capacity to ensure all reporting activities are completed in compliance with regulations and client contractual obligations.
Collaboration & Communication:
- Work closely with project team members, client contacts, investigators, and third-party vendors to ensure the smooth execution of safety reporting activities.
- Represent the Safety Reporting department in client meetings and internal discussions, providing updates on project status and addressing any issues as needed.
Quality Control & Filing:
- Maintain and update project information within pharmacovigilance databases, ensuring timely and accurate data entry.
- Oversee the filing and quality control of documents in eTMF or agreed filing solutions, ensuring file readiness for audits or inspections.
- Prepare for audits and inspections, providing necessary documentation and support.
Mentoring & Training:
- Mentor and coach less experienced associates on safety reporting activities.
- Assist in the training and development of new team members on pharmacovigilance processes and regulatory requirements.
Regulatory Knowledge:
- Stay updated on current regulations and safety reporting practices to ensure compliance with the latest industry standards.
- Review regulatory and safety reporting intelligence documents to ensure ongoing alignment with regulatory requirements.
Additional Duties:
- Perform additional project activities as requested, including presentations at client or investigator meetings, client correspondence, and escalating issues as needed.
- Travel (approximately 10%) domestically or internationally to support project needs.

What ICON Can Offer You

At ICON, our success depends on the quality of our people. We offer a range of benefits designed to support your well-being and work-life balance, including:

Competitive salary and annual leave entitlements.
Flexible health insurance options tailored to you and your family’s needs.
Retirement planning offerings for long-term financial security.
Global Employee Assistance Program offering 24/7 support for personal and family well-being.
Optional benefits like childcare vouchers, gym memberships, and subsidized travel passes.

Diversity & Inclusion at ICON

We believe that diversity, inclusion, and belonging are key to our success. Our rich diversity drives innovation, enabling us to better serve our patients, clients, and communities. ICON is committed to creating an accessible and inclusive environment for all candidates and ensuring a workplace free of discrimination and harassment.

Interested in the Role?

If you are passionate about pharmacovigilance and clinical research, and want to contribute to our global mission, we encourage you to apply. Don’t worry if you don’t meet all the requirements – we welcome diverse talents and experiences!

[Apply here] (Insert application link)
If you’re a current ICON employee, please apply via the internal portal.

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 :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh | Roorkee |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

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 | Ft MItchell | 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 | Macomb | Southfield |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | 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 | Oeiras | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Knoxville | Memphis | Nashville |

Texas :

United states :

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Appleton | Pleasant Prairie | 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

Belgium :

Wavre |

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in Ireland

Carlow :

Carlow |

Cork :

Brinny | Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Meath :

Dunboyne |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Tipperary :

Ballydine |

Ulster :

Donegal |

Pharma Jobs in China

China :

China | Quarry Bay |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

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 |

North Brabant :

Breda |

South Holland :

Leiden |

Pharma Jobs in England

North Yorkshire :

Harrogate |

Oxfordshire :

Witney |

South Yorkshire :

Sheffield |

United Kingdom :

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 & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & New Zealand & Peru & 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 |

Flemish Brabant :

Zaventem |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

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 :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

North Island :

Auckland |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

South Africa | Midrand |

Brazil :

Brazil | Sao paulo |

South America :

Peru | 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 |

Pharmacovigilance Reporting Associate

Job Description

About ICON plc

Role Overview

Key Responsibilities

What ICON Can Offer You

Diversity & Inclusion at ICON

Interested in the Role?

Latest Jobs

Global Medical Maintenance Expert

R&D Data Modeling Manager Associate

Genotoxicity Expert

R&D Clinical Eds

R&D Senior Eds Specialist

Senior Medical Regulatory Writer

Senior Biostatistician Biomarker

Senior Scientific Writer

Associate Scientific Writer

Scientific Writer