Icsr Group Head ( General Manager)

15+ years

Not Disclosed

Remote

10 Nov. 26, 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: ICSR Group Head (General Manager)
Company: [Company Name]
Job Type: Full-Time
Experience: 15-20 Years
Location: [Not specified]

Job Summary:

The ICSR Group Head (General Manager) is responsible for overseeing the entire ICSR operations, ensuring quality and compliance in activities such as literature screening, health authority submissions, case processing, data entry, and quality assurance. This leadership role involves managing teams, driving continuous improvement, and collaborating with cross-functional stakeholders to enhance ICSR processes and outcomes.

Key Responsibilities:

Leadership: Lead and manage an integrated ICSR management team, overseeing case intake, processing, and reporting functions to ensure efficiency and compliance.
Compliance & Quality: Ensure adherence to global regulations, internal procedures, and quality standards across ICSR activities, maintaining timelines and compliance.
Team Development: Manage and mentor a team of ICSR team leads, reviewers, specialists, and quality checkers responsible for end-to-end ICSR activities from booking to submission.
Cross-Functional Collaboration: Coordinate with other Pharmacovigilance (PV) functions, external vendors, and cross-functional stakeholders to ensure the smooth operation of ICSR activities, aligning processes and resolving issues.
Performance Monitoring: Monitor and report on key metrics such as ICSR processing volume, quality, timeliness, compliance rates, and productivity.
Process Improvement: Identify, implement, and drive process improvements and best practices, such as optimizing workflows, standardizing procedures, and enhancing quality checks.
Audit & Inspection Support: Provide support for audits and inspections related to ICSR operations, preparing for audit readiness, addressing findings, and implementing corrective and preventive actions.

Job Requirements:

Experience: 15-20 years of relevant experience in Pharmacovigilance (PV), with a focus on ICSR operations.
Education: Master’s degree in Pharmacy, Life Sciences, or a related field.
Skills and Competencies:
- Expertise in PV regulations and guidelines for ICSR operations.
- Strong knowledge of ICSR reporting, documentation, tools, and systems.
- Proven experience in quality assurance, compliance, and team leadership.
- Excellent communication, coordination, problem-solving, and decision-making skills.

Apply Now

If you are an experienced leader in Pharmacovigilance and ready to take charge of ICSR operations with a focus on quality, compliance, and continuous improvement, apply today.

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 |

India :

Siliguri |

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 | Enfield | Groton | Storrs |

D.C :

Washington |

Florida :

Georgia :

Atlanta |

Hawaii :

Honolulu |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Lawrence |

Kenlucky :

Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maryland :

Baltimore | Elkridge | Gaithersburg | Rockville |

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Minneapolis and St. Paul, Minnesota. | St.Paul |

Missouri :

Fulton | St. Louis |

Nevada :

Las Vegas |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Santa Fe |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

Ohio :

Cincinnati | Cleveland | Columbus, | Macedonia |

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Nashville |

Texas :

United states :

Georgia | United States |

United States :

Hawai | Sylmar |

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 | 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

Hubei :

Wuhan |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Pharma Jobs in Argentina & Australia & Austria & Belgium & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Finland & France & Greece & Indonesia & Ireland & Israel & Italy & Japan & Kazakhstan & Korea & Netherland & Philippines & Portugal & Remote & Saudi Arabia & Singapore & South Afrcia & South America & Spain & Taiwan & Tennessee & Thailand & Turkey & United Arab Emirates

Buenos Aires :

Buenos Aires |

New South Wales :

Sydney |

Queensland :

Queensland |

Republic of Western Australia :

Nedlands |

Austria :

Austria |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Canada :

Canada |

Ontario :

North York | Richmond Hill |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

United Kingdom :

Estonia :

Estonia |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Greece :

Greece |

Jakarta :

Jakarta |

Cork :

Ringaskiddy |

County Dublin :

Swords |

Republic of Ireland :

Limerick | Waterford | Dublin |

Israel :

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

Italy :

Italy |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Republic of Korea :

Seoul |

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

Philippines :

Manila |

Remote :

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

Makkah :

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Dubai :

Dubai |

Icsr Group Head ( General Manager)

Job Description

Job Summary:

Key Responsibilities:

Job Requirements:

Apply Now

Latest Jobs

Cra Ii / Senior Cra - Sponsor Dedicated - Bulgaria

Clinical Research Associate Ii

Senior Manager, Pharmacovigilance

Principal Biostatistician

Project Analyst

Associate Project Manager, Business Operations

Clinical Operations Assistant

Director, Clinical Quality Assurance

Sr Drug Safety Associate I

Senior Specialty Representative - Iss Team (Primary Care) - Rockford, Il

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in China