Senior Pharmacovigilance Specialist

5+ years

Not Disclosed

Bangalore Noida

10 July 25, 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, 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: Senior Pharmacovigilance Specialist

Location: Hybrid Work Model
Hours: Full-time, Monday to Friday

Overview:

We are seeking a Senior Pharmacovigilance Specialist to join our Pharmacovigilance (PV) team. This role offers a unique opportunity to contribute to literature monitoring, adverse event reporting, and indexing by leveraging extensive knowledge of scientific and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

Key Responsibilities:

Literature Analysis: Critically analyze a high volume of biomedical articles and internal drug safety alerts to identify individual case safety reports (ICSRs) and other safety-relevant information that could impact the risk-benefit and/or safety profile of our customers' products.
Narrative Writing: Write concise and accurate narratives summarizing ICSR criteria and other relevant safety information from each article.
Safety Assessment: Demonstrate a thorough understanding of client drug labels to effectively perform safety assessments.
Timely Reviews: Complete drug safety reviews for biomedical literature batches promptly and accurately, adhering to client standards and quality requirements.
Data Tracking: Use a drug safety system to track all actions and assessments, maintaining an audit-ready reference history.
Database Management: Select articles relevant to the client's interests for inclusion in the product literature database according to guidelines.
Abstracting and Indexing: Write detailed and complete abstracts of selected articles, ensuring precise and comprehensive indexing for accurate literature retrieval.
Knowledge Maintenance: Stay updated on new drugs, therapeutic categories, disease entities, and changes in biomedical terminology.

About You:

Education: Master’s Degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics). A degree in Dentistry, Physiotherapy, or Nursing is a plus.
Experience: At least 5-6 years of experience reviewing biomedical literature for adverse event reporting, or an equivalent combination of education and experience. Experience in drug safety/pharmacovigilance is desirable.
Skills: Strong analytical ability, excellent writing skills for creating precise summaries, and in-depth knowledge of biomedical terminology and therapeutic areas. Proficiency in database and literature searches is required.
Communication: Excellent interpersonal, verbal, and written communication skills, with a client-focused approach to work. Ability to work collaboratively in a team environment and independently draw conclusions from data.
Organization: Ability to manage multiple tasks, prioritize workloads, and pay attention to detail.

Desirable Skills:

Certification from a professional medical writer’s association.
Experience with commercial and client-specific biomedical literature databases.
Background in scientific or medical writing.

About the Team:

Our PV Literature team supports a diverse range of customers across all therapeutic areas. We provide a supportive work environment with personalized training and opportunities for engagement in various aspects of pharmacovigilance, including participation in customer upgrade planning.

Equal Opportunity Statement:

Clarivate is dedicated to offering equal employment opportunities for all individuals. We comply with all applicable laws and regulations governing non-discrimination in employment.

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 :

Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Denver |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Lawrence | McPherson |

Kenlucky :

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 |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh |

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 | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | United States |

United States :

Hawai | Sylmar |

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

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

China :

China |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Australia

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

South Holland :

Leiden |

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 & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & 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 |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Richmond Hill | Uxbridge | North York | Mississauga |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

South Yorkshire :

Sheffield |

United Kingdom :

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 :

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

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Senior Pharmacovigilance Specialist

Job Description

Position: Senior Pharmacovigilance Specialist

Latest Jobs

Production Planner

Senior Quality Assurance And Regulatory Affairs Analyst

Senior Analyst - Design Quality Assurance

Senior Technician - Quality Control

Quality System Specialist (Qms)

Development Scientist I (Bangalore)

Trial Master File Specialist

System Associate, Information Technology

Senior Clinical Research Associate Contractor