• Login / Signup
    • Instagram
    youtube
    Facebook

    Medical Director, Patient Safety Physician

    Astrazeneca
    10+ years
    Not Disclosed
    Boston
    10 July 24, 2024
    Job Description
    Job Type: Full Time Education: MD, MBBS 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

    Job Title: Medical Director, Patient Safety Physician

    Career Level: F
    Location: [City, State/Region, Country]
    Company: AstraZeneca

    Role Overview:

    As the Medical Director, Patient Safety Physician, you will be responsible for developing and executing the clinical safety strategy for AstraZeneca’s drug projects and products. This role encompasses all stages of drug development, including market presence. Your primary focus will be on implementing and communicating safety strategies, evaluating adverse events, managing risk, and ensuring compliance with global regulatory requirements. You will report to the Senior Medical Director and work collaboratively with cross-functional teams to ensure the safety and efficacy of our products.

    Key Responsibilities:

    Safety Governance and Risk Management:

    • Develop and implement the clinical safety strategy for assigned AstraZeneca drug projects and products throughout their lifecycle, including late-stage development and post-marketing phases.
    • Define and communicate identified and potential risks, propose mitigation strategies, and establish safety criteria for clinical programs.
    • Review and endorse Patient Risk Management Plans (PRMP) and provide expertise for pharmacovigilance plans and risk minimization activities.
    • Represent Patient Safety (PS) on cross-functional Clinical and Project Teams for developmental and marketed products.
    • Provide strategic input into clinical development planning and review safety-related project requirements and documents.

    Signal Detection, Evaluation, and Labelling:

    • Oversee safety surveillance activities, including medical review of individual safety cases, signal detection, and evaluation.
    • Provide medical input for regulatory documents and labeling updates, utilizing appropriate information sources and database searches.
    • Collaborate with external providers and discuss data evaluation results with key stakeholders.
    • Prepare and manage safety information documents, including Developmental Core Safety Information (DCSI) and responses to regulatory requests.

    Regulatory Reports and Submissions:

    • Review and provide medical input for periodic safety reports (e.g., PBRERs, PSURs, DSURs) and regulatory submissions (e.g., NDA, BLA, MAA).
    • Contribute to safety agreements and licensing agreements, and support due diligence activities as needed.

    Other Activities:

    • Participate in and lead process improvement initiatives and contribute to advancements in methodology and processes.
    • Mentor and train junior team members in signal evaluation, risk management, and safety report preparation.
    • Ensure personal readiness for internal audits and regulatory inspections, and collaborate effectively with cross-functional and external teams.

    Required Qualifications:

    • Medical degree (e.g., MD, MBBS).
    • At least 2 years of clinical experience post-registration preferred.
    • Minimum of 11-13 years of experience in patient safety, with clear evidence of successful delivery.
    • Extensive knowledge of the pharmaceutical/biopharmaceutical industry, particularly in clinical research, safety reporting, and risk management.

    Skills and Capabilities:

    Leadership:

    • Strong commitment to customer service and integrity.
    • Strategic leadership with the ability to identify opportunities and drive accountability.
    • Effective collaboration and development of people and organizations.

    Technical Expertise:

    • In-depth understanding of drug development and disease areas.
    • Expertise in pharmacovigilance and patient benefit-risk assessment.
    • Integrative thinking and excellence in safety evaluation.

    Core Competencies:

    • Conceptual thinking and influencing skills.
    • Initiative and innovation in improving practices and business relationships.
    • Strong business relationship management and negotiation skills.

    Why Join Us?

    AstraZeneca is committed to building a diverse and inclusive team that represents a wide range of perspectives and skills. We believe that diversity enhances our work and drives innovation. We welcome applications from all qualified candidates and comply with all applicable laws and regulations regarding non-discrimination, work authorization, and employment eligibility verification.

    Apply today to be part of our mission to advance science and improve patient outcomes!

    Latest Jobs

    Manager, Cmc

    Pfizer
    Beijing

    Regulatory Affairs Department Assistant(Contractor)

    Pfizer
    Turkey

    Senior Scientist, Protein Chemistry

    Pfizer
    Remote, USA

    Medical Science Liaison

    Pfizer
    Philippines

    ​​Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences​

    Pfizer
    Remote, USA

    Associate Central Monitor, Data Surveillance, Clinical Data Sciences

    Pfizer
    Remote, USA

    Clinical Research Associate

    Clinexel Life Sciences Pvt. Ltd.
    Mumbai

    Project Manager

    Clinexel Life Sciences Pvt. Ltd.
    Mumbai

    Biostatistician

    Clinexel Life Sciences Pvt. Ltd.
    Mumbai

    Database (Programming) Analyst (Associate), Clinical Data Management

    Pfizer
    Remote, USA

    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 |

    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

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | 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 |

    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 | Syracuse |

    North Caroline :

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

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

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

    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 |

    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 Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Tokiyo :

    Tokyo | Osaka |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    London | Salt Lake City |

    Republic of Ireland :

    Limerick | Dublin |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

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

    Makkah :

    Najran | Riyadh | Rabigh | Jeddah | Khulais |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |