Manager, Safety & Pharmacovigilance (Icsr)

Syneos Health

8+ years

Not Disclosed

Hyderabad

10 Dec. 31, 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

Manager – Safety & Pharmacovigilance (ICSR)

Job ID: 25103579
Location: Hyderabad, Telangana, India
Employment Type: Full-Time | Consulting
Company: Syneos Health®
Updated: December 29, 2025

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage clinical, medical affairs, and commercial insights to deliver outcomes that address modern healthcare challenges.

Our Clinical Development model places the patient and customer at the center, streamlining processes to enhance efficiency for both clients and employees. With a global team of 29,000 professionals across 110 countries, Syneos Health combines innovation, expertise, and collaboration to deliver impactful healthcare solutions.

Job Overview

The Manager – Safety & Pharmacovigilance (ICSR) will oversee pharmacovigilance operations, manage ICSR case processing, ensure regulatory compliance, and lead a high-performing team. This role involves strategic oversight, process optimization, quality management, and mentoring of team members to maintain excellence in drug safety and patient care.

Key Responsibilities

Leadership & People Management:

Lead, mentor, and manage Safety & Pharmacovigilance team members, including hiring, transfers, terminations, training, and performance appraisals.
Approve timesheets, manage utilization, and provide guidance on administrative policies, technical issues, and prioritization.
Provide career development and professional coaching to team members.

Project & Operational Management:

Assign project work, review workloads, and monitor team performance against Safety Management Plans.
Oversee projects where Safety & Pharmacovigilance is the primary service, ensuring adherence to budgets, study timelines, and contractual obligations.
Approve project invoicing and collaborate with Finance to ensure accurate billing.
Coordinate with internal departments to ensure timely review and submission of safety reports and resolution of safety issues.

Regulatory & Quality Compliance:

Ensure compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP modules, study plans, and global drug regulations.
Participate in audits, inspections, and quality investigations, implementing corrective and preventive actions.
Review and approve safety components of study protocols, Case Report Forms (CRFs), and project proposals.

Process Improvement & Strategy:

Evaluate workflows for efficiency and effectiveness, recommending improvements and optimizing departmental processes.
Develop dashboards, reports, and visual performance metrics for management.
Support business development activities and represent Safety & Pharmacovigilance in client meetings and project teams.

Training & Development:

Identify training needs, prepare and deliver training sessions for Safety team members and other departments.
Foster a collaborative and knowledge-sharing environment to support continuous professional development.

Additional Responsibilities:

Manage resourcing needs, escalate issues to senior management, and perform other duties as assigned.
Minimal travel may be required.

Required Qualifications

BA/BS in Biological Sciences, Nursing, Life Sciences, or a related healthcare discipline.
Minimum 8+ years of experience in Pharmacovigilance, including 5+ years of people management.
Experience in Clinical Research Organizations (CROs) and knowledge of therapeutic specialties preferred.
Proficiency in ARGUS / ARISg Safety Databases; SQL and Power BI knowledge is advantageous.
Strong financial acumen for budget monitoring, invoicing, and project cost management.

Key Skills and Competencies

Excellent leadership, project management, and interpersonal skills.
Strong oral, written, and presentation skills with proficiency in Microsoft Office Suite.
Ability to manage multiple priorities in a dynamic, matrix environment.
Flexible, adaptive, and capable of independent and collaborative work.
Ability to establish effective relationships with clients and internal teams globally.

Recommended 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 :

Brazil | Sao paulo |

Attica :

Koropi | Athens |

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 :

Saitama | Japan |

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 :

Midrand | South Africa |

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, Safety & Pharmacovigilance (Icsr)

Job Description

Recommended Jobs

Manager, Centralized Study Support

Senior Manager, Clinical Programming

Associate Manager, Medical Communications And Content Solutions

Senior Manager, Medical Communications And Content Solutions (Mccs)

Sr Manager, Statistical Programming

Associate Manager Safety Data And Pv Systems

Senior Manager, Patient Safety Scientist

Clinical Operations Manager, Fsp 360, India, Home Based

Senior Manager, Established Brands Regulatory Lead

Associate Project Manager, Scientific Communications