• Login / Signup
    • Instagram
    youtube
    Facebook

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

    Legend Biotech Us
    5+ years
    Not Disclosed
    Remote, USA
    10 Nov. 18, 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, 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

    Sr. Medical Director - Drug Safety & Pharmacovigilance (Remote)
    Location: United States

    Company Overview
    Legend Biotech is a global biotechnology leader focused on advancing therapies for life-threatening diseases. Based in Somerset, New Jersey, we specialize in innovative cell therapies across various platforms, including autologous and allogenic chimeric antigen receptor T-cell (CAR-T) and natural killer (NK) cell-based immunotherapies. Our strategic collaboration with Janssen (Johnson & Johnson) aims to develop and commercialize cilta-cel for treating multiple myeloma.

    Position Overview
    We are seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance to join our Clinical Development Team. This pivotal role will provide safety strategy and expertise, guiding clinical development projects while ensuring compliance with global regulatory standards. You will play a critical role in risk management, signal detection, and managing the safety profile of our compounds. The position involves cross-functional collaboration and ensuring alignment across studies to meet project goals within set timelines.

    Key Responsibilities

    • Lead pharmacovigilance strategy and activities to align with corporate clinical and commercial objectives.
    • Conduct signal detection, monitoring, and safety data interpretation to manage safety risks.
    • Lead Safety Monitoring Team (SMT) meetings to evaluate the benefit-risk profile of compounds.
    • Perform medical safety reviews and causality assessments across multiple data sources (preclinical, clinical, post-marketing).
    • Provide medical input into critical clinical development documents (INDs, NDA/BLA, protocols, ICFs).
    • Oversee Urgent Safety Measures and aggregate reports for assigned projects.
    • Engage with regulatory authorities on safety topics, ensuring timely and accurate clinical content for inquiries.
    • Manage and provide leadership to CRO teams, ensuring effective service delivery and vendor oversight.
    • Develop and manage the drug safety budget, resources, and expenses.
    • Support internal and external meetings, including governance and regulatory authority sessions.
    • Identify project risks, develop mitigation strategies, and provide transparent updates to senior leadership.
    • Lead team coaching and performance management activities to foster high performance.
    • Ensure adherence to corporate policies and healthcare regulations.
    • Participate in process improvements and departmental training initiatives.

    Requirements

    • MD, MBBS, MD-PhD, or equivalent medical degree.
    • Minimum 5 years of experience in Drug Safety & Pharmacovigilance.
    • Strong knowledge of pharmacovigilance regulations in the US and EU.
    • Experience in supporting drug safety in clinical registrational studies.
    • Expertise in drug development from discovery through registration and post-marketing surveillance.
    • Proven leadership experience in a matrix environment, managing teams and ensuring goal achievement.
    • Experience in IND, NDA/BLA filings and regulatory interactions is highly desirable.
    • Experience in biotech is a plus but not required.

    Legend Biotech is an Equal Opportunity Employer
    We are committed to creating a diverse, inclusive workforce and ensuring equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, or any other characteristic protected by law. We maintain a drug-free workplace.

    Latest Jobs

    Clinical Documents Management Specialist

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Associate Medical Director - Migraine Eu

    Teva Pharmaceuticals
    Haarlem

    Qa Ra Specialist

    Katalyst Healthcares & Life Sciences
    Baltimore

    Director, Medical Affairs - Multiple Therapy Areas

    Teva Pharmaceuticals
    Harlow

    Regulatory Affairs Specialist, Medical Device

    Katalyst Healthcares & Life Sciences
    Baltimore

    Validation Lead

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Contract Medical Writer

    Katalyst Healthcares & Life Sciences
    Remote

    Senior Manager, Pharmacovigilance

    Icon
    Remote, USA

    Clinical Research Associate Ii

    Icon
    Remote, USA

    Associate Medical Director - Neurology & Psychiatry, Medical Affairs Europe

    Teva Pharmaceuticals
    Amsterdam

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |

    California :

    Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Rockville |

    Massachusetts :

    Boston | Cambridge | Medford and Somerville | Rockland |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New York :

    Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |

    North Carolina :

    Concord |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

    Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Istanbul :

    Turkey |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Australia & Canada & Colombia & Croatia & Egypt & England & Indonesia & Ireland & Israel & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Quebec :

    Montreal |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Salt Lake City | London | Harlow |

    Jakarta :

    Jakarta |

    Republic of Ireland :

    Dublin | Limerick |

    Israel :

    Tel Aviv | Netanya | Kfar Saba |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Noord Holland :

    Haarlem |

    Remote :

    Remote - Europe | Switzerland | Remote, USA | Remote |

    Makkah :

    Rabigh | Riyadh | Jeddah | Najran | Khulais |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |