Safety & Pv Specialist I (Gurugram / Pune)

3-5 years

Not Disclosed

Gurugram

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./ B. Pharm/M. Pharm/ BDM/ BMS/ BDS /Life science 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

Safety & PV Specialist I (Gurugram / Pune)
Updated: March 13, 2025
Location: India-Asia Pacific - IND-Gurugram-DLF Downtown
Job ID: 25002008

Description

Safety & Pharmacovigilance Specialist II

Syneos Health® is a fully integrated biopharmaceutical solutions organization, accelerating customer success by translating unique clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model prioritizes the customer and the patient, constantly seeking to simplify and streamline processes to enhance both customer and employee experiences.

Why Syneos Health

Career development and progression opportunities
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and a total rewards program
Commitment to a Total Self culture where authenticity and diversity are valued

Job Responsibilities:

Enter information into PVG quality and tracking systems for ICSR receipt and tracking.
Assist in preparing project plans like Safety Management Plans.
Manage the setup, delivery, and close-out of safety and pharmacovigilance projects.
Process ICSRs per SOPs and project-specific safety plans.
Triage ICSRs, evaluate data for completeness, accuracy, and regulatory reportability.
Enter data into the safety database and code events, medical history, concomitant medications, and tests.
Compile complete narrative summaries and assess information for queries, ensuring satisfactory resolution.
Generate timely, consistent, and accurate expedited reports per regulatory requirements.
Coordinate with data management staff for safety data reconciliation.
Maintain safety tracking for assigned activities.
Perform literature screening, drug coding, MedDRA coding, and validation of xEVMPD product records.
Handle manual recoding of un-recoded product and substance terms.
Manage duplicate ICSRs and handle activities related to SPOR/IDMP.
Conduct quality reviews of ICSRs and peer-reviewed work.
Serve as a subject matter expert in SPVG, resolving routine queries and mentoring new hires.
Ensure distribution of all required individual expedited and periodic reports.
Participate in audits/inspections as required.
Ensure relevant documents are submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File.
Maintain compliance with SOPs, Work Instructions (WIs), regulations, GCP, ICH guidelines, GVP, project plans, and the drug development process.

Qualifications:

Education: Bachelor's Degree in life science, pharmacy (B. Pharm/M. Pharm), or a related field. No BSC/MSC candidates.
Experience: 3-5 years of relevant Safety/Pharmacovigilance ICSR case processing experience.
Technical Skills: Experience with Safety Database systems (ARGUS), knowledge of medical terminology, and proficiency in Microsoft Office Suite.
Knowledge: Understanding of clinical trial processes (Phases II-IV), post-marketing safety requirements, ICH GCP, GVP, and related regulations.
Skills: Strong communication, interpersonal, organizational, and multitasking abilities. Detail-oriented with high accuracy and ability to meet deadlines.
Travel: Minimal travel required (up to 5%).

Get to Know Syneos Health

Over the past 5 years, we have collaborated on 94% of FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

Additional Information:
Tasks and responsibilities may be modified at the company’s discretion. Syneos Health complies with the Americans with Disabilities Act and provides reasonable accommodations when appropriate.

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 | 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 :

fairmont | Georgia | OH | United States |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

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 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 Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

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 :

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 |

Safety & Pv Specialist I (Gurugram / Pune)

Job Description

Description

Job Responsibilities:

Qualifications:

Get to Know Syneos Health

Latest Jobs

Sr. Team Leader, Operations

Associate Director, Pharmacovigilance Processes

Pharmacovigilance Services Associate

Associate Medical Coder

Senior Associate - Contracting Operations

Safety & Pv Specialist Ii (Gurugram / Pune)

Clinical Data Associate I

Medical Advisor – Vaf 173

Medical Information Officer/Specialist German - Vaf174

Quality Associate (Rp) – Vaf 183