Manager, Product Surveillance

Baxter

1–2 years

Not Disclosed

Gurgaon

10 Sept. 8, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.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

🏢 Position Title:

Manager, Product Surveillance
Req #: JR-182070
Location: Gurgaon, Haryana, India
Company: Baxter International Inc.

🧭 Position Overview

Join Baxter’s Quality team where your role contributes directly to patient safety and regulatory compliance. As Manager, Product Surveillance, you will lead a team responsible for end-to-end complaint processing in accordance with global regulatory standards. You will provide subject matter expertise on post-market surveillance and ensure effective team performance, compliance, and operational excellence.

🎯 Key Responsibilities

✅ Team & Process Management

Manage the Product Surveillance team, including hiring, mentoring, coaching, and performance evaluation.
Assign daily complaint processing tasks to ensure timely regulatory reportability determination and reporting.
Monitor and improve key performance indicators (KPIs) and operational metrics.

🧠 Subject Matter Expertise

Act as a Subject Matter Expert (SME) for post-market surveillance processes.
Provide guidance and oversight for complaint handling, regulatory submissions, and product safety reviews.
Review and revise SOPs and quality procedures as needed.

📊 Reporting & Analysis

Regularly update management on team performance, risk trends, and escalations.
Analyze operations metrics and identify opportunities for process improvements.

🔍 Audit & Compliance

Lead or support audit readiness for internal and external audits.
Represent the team during audits by regulatory bodies (e.g., FDA, ISO auditors), including responding to observations and implementing corrective actions.
Support NCRs/CAPAs, risk mitigations, and ensure compliance to regulatory standards.

🤝 Cross-functional Collaboration

Partner with Quality, Engineering, Regulatory Affairs, and other departments.
Participate in or lead cross-functional projects related to complaints, CAPA, or post-market activities.

📌 Qualifications & Skills

🎓 Education

Bachelor’s degree in Science or Engineering (preferred).

💼 Experience

5+ years in Quality, Engineering, Manufacturing, or related field.
Minimum 1–2 years of experience in a supervisory role or
7+ years of relevant experience in Product Surveillance.

🧠 Technical & Soft Skills

In-depth understanding of FDA and ISO regulations, especially as they relate to complaint handling and post-market surveillance.
Strong leadership and people management capabilities.
Excellent critical thinking, problem-solving, and decision-making skills.
Proficiency in technical writing, documentation review, and procedural compliance.
Ability to drive team performance and maintain audit readiness.
Comfort with ambiguity and complex regulatory frameworks.

💡 Success Profile:

Detail Oriented
Critical Thinker
Collaborative
Continuous Learner
Courageous
Influential

🌱 Benefits at Baxter

Support for Parents
Continuing Education & Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year for Volunteering

📍 Work Location

Baxter (India) Pvt. Ltd
5th Floor, Tower A, Building No.9
DLF Cyber City, DLF Phase III
Gurgaon – 122002, Haryana, India

🌐 Equal Employment Opportunity

Baxter is an Equal Opportunity Employer. All qualified applicants are considered without regard to race, religion, gender, disability, sexual orientation, or veteran status.

♿ Reasonable Accommodations

If you need reasonable accommodation due to a disability or medical condition during the application process, click here to contact Baxter’s accommodation support.

⚠️ Recruitment Fraud Alert

Be cautious of recruitment fraud. Baxter will never request personal financial information or payment during the recruitment process. Learn more by reviewing Baxter’s Recruitment Fraud Notice.

📩 Apply Now

Click here to apply (Insert official application link)

Latest Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

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

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Peru | Argentina |

Brazil :

Sao paulo | Brazil |

Attica :

Athens | Koropi |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

Ciudad de México | New Mexico |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Paris | Lyon |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Manager, Product Surveillance

Job Description

Latest Jobs

Associate Medical Director/Medical Director - Gastroenterology/Hepatology

Associate Medical Director/Medical Director - Cardiology

Global Medical Safety Lead(Medical Director) - Remote U.S/Canada

Sr. Cdm Programmer (Edc)

Principal Reg Affairs Assistant

Scientist Iii, Molecular Biology

Creative Operations Specialist

Hplc & Ic Field Service Engineer

Associate Manager Safety Data And Pv Systems

Market Development Manager- Food Safety