Associate Project Manager, Patient Safety

4-6 years

Not Disclosed

Shanghai Shi

10 Sept. 23, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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: Associate Project Manager, Patient Safety
Location: Shanghai, China
Category: Clinical
Job ID: 254618

Job Overview

The Associate Project Manager, Patient Safety, oversees project-specific Patient Safety Solutions (PSS) operations, managing the full adverse event (AE) process from clinical trials and post-marketing sources. The role ensures timely, accurate, and compliant safety reporting, provides leadership and mentorship to project teams, and maintains high-quality service to internal and external stakeholders.

Key Responsibilities

Project Leadership & Management

Lead global or regional projects, ensuring harmonized communications and processes.
Monitor and manage project workflow to meet deadlines and ensure compliance with safety reporting regulations, SOPs, and departmental guidelines.
Make decisions regarding AE reporting within project-specific guidelines.
Provide oversight for all PSS activities, ensuring regulatory and contractual compliance.
Monitor deliverables against contract assumptions, identify out-of-scope work, and prevent budget overruns.
Contribute to Time and Cost Estimates for PSS business.

Adverse Event Processing & Oversight

Oversee receipt and processing of AE reports (spontaneous or clinical trial).
Ensure data entry, AE review, narrative writing, MedDRA coding, and listedness assessments are completed accurately.
Ensure appropriate medical review and follow-up for missing information.
Prioritize expedited reporting to clients, regulatory authorities, ethics committees, investigators, and internal stakeholders.
Oversee Expedited Safety Reports (ESRs) and endpoint reporting.
Maintain knowledge of safety database conventions and system functionality.

Quality Assurance & Compliance

Conduct routine quality reviews of AE reports and aggregate reports.
Oversee EudraVigilance activities and ensure compliance with global regulatory standards.
Participate in signal detection, trend, and pattern recognition activities.
Prepare Safety Management Plans (SMPs), Reconciliation Plans, and other project-specific safety plans.
Contribute to the development and review of SOPs, Work Instructions (WIs), and departmental guidance.
Prepare for audits and inspections, ensuring quality and regulatory compliance.

Training, Mentorship & Communication

Train and mentor project team members and less experienced colleagues in AE processing and PSS operations.
Cascade information from internal and external meetings to PSS management and colleagues.
Attend client meetings, provide oversight, and maintain strong client relationships.
Prepare and deliver safety presentations for investigators, clients, and internal stakeholders.

Additional Responsibilities

Supervise workloads and individual performance of junior team members.
Manage the review of cumulative safety data for DSMBs, regulatory authorities, or clients.
Coordinate Safety Committees, endpoint committees, and data reconciliation with Data Management or clients.
Contribute to Clinical Trial Protocols, Case Report Forms, and AE Reporting forms.
Perform additional duties as assigned.

Qualifications

Minimum Required

Education and experience options:
- Non-degree: 6–7 years Safety experience
- Associate degree: 5–6 years Safety experience
- Associate degree RN: 5–6 years Safety experience
- BS/BA: 4–5 years Safety experience
- MS/MA: 2–3 years Safety experience or 3–4 years relevant experience
- PharmD: 1–2 years Safety experience or 2–3 years relevant experience (1-year residency/fellowship may count)
Degree preferred in Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry

Experience & Skills

Compliance with client and global regulatory requirements.
Knowledge of worldwide pharmacovigilance regulations and guidelines, GCP, ICH guidelines, and medical/drug terminology.
Experience with AE/SAE processing, database management, narrative writing, and regulatory submissions.
Leadership and mentorship skills; ability to anticipate and resolve problems.
Knowledge of aggregate reporting, risk management, and pharmacovigilance regulatory environment.
Good verbal, written, and presentation skills.
Financially intuitive and able to manage project budgets.
EudraVigilance certification preferred.
Knowledge of Medical Device Reporting desirable.

Work Environment

Office-based environment
Travel: 10–15% (may include overnight stays)

Keywords / Related Roles

Pharmacovigilance
Patient Safety Solutions
AE/SAE Reporting & Oversight
Safety Project Management
Signal Detection & Trend Analysis
Regulatory Compliance
EudraVigilance

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 :

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 | Augusta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

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 :

Albuquerque | 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 :

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 | Vedant |

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 |

Galway :

Galway |

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 :

Arkansas | 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 :

Chessington | 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 :

Koropi | Athens |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Saitama | Japan |

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 :

Sao paulo | Brazil |

South America :

Argentina | Peru |

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 |

Associate Project Manager, Patient Safety

Job Description

Job Overview

Key Responsibilities

Qualifications

Work Environment

Keywords / Related Roles

Latest Jobs

Core Icf Developer/Writer And Reviewer (Centralized Role)

Principal Statistical Programmer - Sponsor Dedicated

Lead Statistical Programmer - Sponsor Dedicated

Senior Pharmacokineticist

Medical Physician Specialist I

Medical Contact Center Associate Ii (French Speaker)

Snr Mgr Ps

Assistant Ii , Pss

Asst I Pss

Specialist Ii, Patient Safety Solutions