Sr. Medical Director - Drug Safety And Pharmacovigilance (Remote)

Lifelancer

10+ years

Not Disclosed

Remote, USA

10 Nov. 5, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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: Sr. Medical Director - Drug Safety and Pharmacovigilance (Remote)
Location: United States (Remote)
Duration: Full-Time
Payrate: Competitive, Based on Experience

About Legend Biotech:

Legend Biotech is a global biotechnology company focused on developing innovative therapies to treat life-threatening diseases. Headquartered in Somerset, New Jersey, the company specializes in advanced cell therapies, including chimeric antigen receptor T-cell (CAR-T) and natural killer (NK) cell-based immunotherapy. Legend Biotech is collaborating with Janssen, a pharmaceutical division of Johnson & Johnson, to develop and commercialize ciltacabtagene autolecuel (cilta-cel) for the treatment of multiple myeloma. With a mission to cure and treat devastating diseases, Legend Biotech is committed to advancing cutting-edge therapies worldwide.

Role Overview:

Legend Biotech is seeking a Sr. Medical Director - Drug Safety and Pharmacovigilance to join the Clinical Development Team. This remote position plays a critical role in drug safety and pharmacovigilance activities throughout the development lifecycle of assigned compounds. The successful candidate will lead safety strategies, drive risk management initiatives, and ensure alignment with regulatory requirements. This individual will be a key contributor to the medical safety review process, signal detection, and safety assessments, while collaborating with cross-functional teams to ensure high-quality, efficient drug development.

Key Responsibilities:

Pharmacovigilance Strategy: Lead and support the development of drug safety and pharmacovigilance strategies to ensure alignment with clinical development and commercial goals.
Signal Detection & Risk Management: Conduct signal detection activities, evaluate safety data, and provide risk-benefit analyses. Manage urgent safety measures in collaboration with cross-functional teams.
Safety Monitoring: Lead Safety Monitoring Team (SMT) meetings to assess and manage safety risks. Present unresolved safety issues to senior management for escalation.
Medical Safety Review: Provide expert medical safety reviews, including causality assessments, for clinical trial data, pre-clinical data, post-marketing surveillance, and literature.
Documentation & Reporting: Oversee the creation of aggregate reports, safety evaluation reports, and responses to regulatory inquiries related to safety topics.
CRO & Vendor Oversight: Lead and ensure effective oversight of Contract Research Organization (CRO) activities and manage external vendor relationships.
Budget & Resource Management: Lead the drug safety budget process and manage resources effectively to ensure timely and successful delivery of safety objectives.
Cross-functional Collaboration: Collaborate with internal and external stakeholders, including clinical, regulatory, and strategic partners, to support global safety initiatives.
Leadership & Team Management: Manage and mentor internal safety scientists and teams, providing leadership to ensure successful project delivery.

Requirements:

Education: MD, MBBS, MD-PhD, or equivalent medical degree required.
Experience: 5+ years in drug safety and pharmacovigilance within the pharmaceutical industry, with expertise in regulatory requirements for the US and EU.
Skills: Strong understanding of pharmacovigilance regulations, signal detection, and risk management. High-level medical competence with the ability to drive business outcomes.
Leadership: Proven experience in managing teams, coaching, mentoring, and driving performance through effective leadership.
Regulatory Experience: Experience with IND, NDA/BLA submissions, and regulatory interactions is highly desirable.
Biotech Experience: Experience in biotech is preferred but not required.
Communication: Excellent communication, organizational, and analytical skills, with the ability to translate complex data into actionable strategies.

How to Apply:

To apply for this position, please visit the following link:
Sr. Medical Director - Drug Safety and Pharmacovigilance Application

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 :

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 :

Hà Nội | Hanoi |

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 :

Lyon | Paris |

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

Sr. Medical Director - Drug Safety And Pharmacovigilance (Remote)

Job Description

About Legend Biotech:

Role Overview:

Key Responsibilities:

Requirements:

How to Apply:

Recommended Jobs

Sr. Cdm Programmer (Edc)

Sr. Cdm Programmer (Edc)

Sr. Medical Writer (Regulatory)

Sr. Medical Writer (Regulatory)

Sr. Director, Clinical Development (Md)- Inflammation/Fibrosis Therapeutic Area

Sr. Ep Field Clinical Specialist - Central/Western Us

Sr. Tmf Specialist

Sr. Tmf Specialist

Sr. Tmf Specialist

Sr. Tmf Specialist

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England