• Login / Signup
    • Instagram
    youtube
    Facebook

    Lead Medical Reviewer

    Navitas Life Sciences
    0-5 years
    Preffered by Company
    Bangalore
    10 Aug. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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 Description: Lead Medical Reviewer

    We are seeking a skilled Lead Medical Reviewer to join our expanding team. In this role, you will oversee medical review activities, ensuring the quality and compliance of safety data across our studies. Your responsibilities will include:

    • Medical Review and Data Assessment:

      • Conducting thorough medical reviews of all Individual Case Safety Reports (ICSRs) from both clinical trials (CT) and post-marketing (PM) studies.
      • Ensuring data completeness in accordance with applicable regulations, standard operating procedures (SOPs), and project-specific guidelines.
      • Reviewing and assessing Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) received from clinical sites.
      • Determining the regulatory reportability of cases, ensuring timely and accurate reporting within the assigned therapeutic team and across all products/sites.

    • Case Management and Documentation:

      • Performing triage to evaluate the seriousness and relatedness of cases across products as assigned.
      • Reviewing and verifying the selection of adverse events from source documents, assigning appropriate MedDRA codes, and assessing expectedness.
      • Reviewing narratives and editing queries based on medical judgment to ensure clarity and accuracy.
      • Analyzing Similar Adverse Event Listings (AOSE) and narratives as needed.

    • Knowledge and Communication:

      • Maintaining up-to-date knowledge of the product portfolio and safety profiles across therapeutic areas.
      • Escalating complex case issues to the client's medical review team when appropriate.
      • Conducting assessments of litigation cases as assigned.
      • Identifying and resolving case issues, coordinating with client therapeutic teams or functional groups as necessary.
      • Communicating effectively within and across client therapeutic teams and functional management.

    • Training and Compliance:

      • Ensuring timely execution and documentation of all required training.
      • Prioritizing cases according to safety management plan timelines and regulatory requirements.
      • Completing assigned cases on a daily basis and communicating with delivery leads or designees regarding case corrections or observed trends.

    Desirable Skills and Experience:

    • Medical Knowledge:

      • Strong understanding of medical and therapeutic terminologies.
      • In-depth knowledge of global, regional, and local clinical regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
      • Familiarity with patient safety regulatory obligations and pharmacovigilance guidelines.

    • Technical Skills:

      • Proficiency in MS Office Suite (Word, Excel, PowerPoint).
      • Strong command of written and spoken English; additional languages are a plus.

    • Soft Skills:

      • Excellent communication skills with the ability to work in a structured and organized manner.
      • Reliable, committed, and motivated with strong teamwork and organizational skills.

    If you meet these qualifications and are excited about the opportunity to contribute to a dynamic team, we encourage you to apply.

    Latest Jobs

    Pssm Generative Ai Practitioner

    Pfizer
    Chennai

    Scientist - Antibody Optimization (Non- Phd)

    Pfizer
    Bothell

    Senior Scientist, Pkpd Modeling & Simulatio Content Link:N

    Pfizer
    Groton

    Senior Scientist, Pkpd Modeling & Simulation

    Pfizer
    La Jolla

    Technical Associate, Animal Care

    Pfizer
    Cambridge

    Associate Scientist (Upstream Process Development)

    Pfizer
    Andover

    Associate Scientist (Upstream Process Development)

    Pfizer
    Andover

    Sr Manager, Crd Operations And External Development

    Pfizer
    Ringaskiddy

    Senior Associate Scientist - Materials Science

    Pfizer
    Groton

    Medical Affairs Scientist

    Pfizer
    Istanbul

    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 |

    Arkansas :

    Fort Smith |

    California :

    Brisbane | Crescent City | Davis | El Monte | El Segundo | Emeryville | Foster City | Fremont | Glendale | 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 | South San Francisco | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Bridgeport | Groton | Storrs |

    D.C :

    Washington |

    Florida :

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

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

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

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    Kenlucky :

    Shelbyville |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Gaithersburg | Rockville |

    Massachusetts :

    Andover | Boston | Cambridge | Devens | Lexington | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | 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 :

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

    North Carolina :

    Concord |

    North Caroline :

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

    Ohio :

    Cincinnati | Cleveland | Columbus, |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

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

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson | Waco |

    United states :

    United States |

    United States :

    Hawai |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bothell | 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 |

    Germany :

    Germany | GErmany |

    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

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen |

    Finland :

    Finland |

    Hungary :

    Budapest |

    Istanbul :

    Istanbul | Turkey |

    Norway :

    Norway | NOrway |

    Romania :

    Romania |

    Serbia :

    Belgrade | Serbia |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Argentina & Australia & Canada & Chile & Colombia & Croatia & Egypt & England & Estonia & France & Indonesia & Ireland & Israel & Japan & Korea & Netherland & Portugal & Remote & Saudi Arabia & Spain & Tennessee & Thailand & Turkey

    Buenos Aires :

    Buenos Aires |

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Canada :

    Canada |

    Ontario :

    Richmond Hill | North York |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Salt Lake City | London | Harlow |

    Estonia :

    Estonia |

    France :

    Paris |

    Jakarta :

    Jakarta |

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Republic of Ireland :

    Dublin | Limerick | Waterford |

    Israel :

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

    Tokyo :

    Otemachi |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Noord Holland :

    Haarlem |

    Remote :

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

    Makkah :

    Khulais | Riyadh | Jeddah | Rabigh | Najran |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |