• Login / Signup
    • Instagram
    youtube
    Facebook

    Senior Medical Director, Patient Safety & Pharmacovigilance (Office Or Remote)

    Arcus Biosciences
    7+ years
    $280,000 - $350,000 USD annually
    Remote, USA
    10 July 22, 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, 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 Medical Director, Patient Safety & Pharmacovigilance
    Location: Hayward or Brisbane, CA (preferred) or Remote
    Salary Range: $280,000 - $350,000 USD annually

    About the Role:

    The Senior Medical Director, Patient Safety & Pharmacovigilance at Arcus Biosciences will lead the safety and pharmacovigilance efforts across our expanding oncology portfolio. This role involves managing safety signals, developing risk management strategies, and ensuring robust benefit-risk assessments for our assets. The ideal candidate will possess extensive experience in oncology safety and demonstrate the ability to work effectively with cross-functional teams and external regulatory authorities. Reporting to the Head of Safety, this leader will directly oversee Safety Physicians and Safety Scientists.

    Responsibilities:

    • Develop and oversee the execution of signal detection strategies for the Arcus portfolio.
    • Prepare and review periodic aggregate reports including IND Annual Reports, Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and EU renewals.
    • Review and contribute to clinical trial protocols, Investigator’s Brochures (IB), Company Core Data Sheets (CCDS), informed consent forms (ICF), and other study documents to align with asset benefit-risk profiles.
    • Lead the creation of developmental risk management plans by gathering input from cross-functional teams.
    • Provide strategic medical input into safety assessments and regulatory authority inquiries.
    • Prepare and review sections of Regulatory Authority submissions such as INDs, NDAs, and Marketing Authorization Applications.
    • Participate in and contribute to Drug Monitoring Committees (iDMC), as applicable.
    • Contribute to scientific publications and presentations for meetings and journals.
    • Support medical safety evaluations for new business development opportunities, including due diligence.
    • Recruit, hire, mentor, and manage direct reports, including conducting performance evaluations.

    Qualifications:

    • M.D. or D.O. degree required; experience in oncology within an academic or hospital setting preferred.
    • 7+ years of relevant experience as a Safety Physician, with a preference for oncology experience involving NDA and BLA submissions.
    • Proven ability to create, evaluate, and maintain effective processes and implement systems to optimize resources within the Safety department.
    • Demonstrated success in a dynamic, fast-paced team environment.
    • Strong track record in building and leading high-performing teams.
    • In-depth knowledge of global pharmacovigilance regulations (EMA, FDA, PMDA, Asia-PAC, ICH).
    • Excellent people and project management skills with a focus on coaching and mentoring.
    • Outstanding interpersonal, communication, analytical, and organizational skills.

    Additional Information:

    Arcus Biosciences offers a competitive salary based on experience and qualifications, stock program participation, performance-based bonuses, and a comprehensive benefits package. For more details about our total rewards program, visit Arcus Careers.

    Equal Opportunity Employer:

    Arcus Biosciences is committed to providing equal employment opportunities to all employees and applicants. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected status. We are dedicated to creating a diverse and inclusive environment where everyone can thrive. EOE/AA/Vets.

    Latest Jobs

    Clinical Research Lead Auditor/Monitor (Oncology Studies) Remote

    Ecog-Acrin Mrf
    Remote, USA

    Infusion Clinical Pharmacist

    Sutter Health
    Dublin

    Manager Research Project B (Department Of Biostatistics, Epidemiology And Informatics)

    University Of Pennsylvania
    Remote - Europe

    Sr. Clinical Trial Project Manager (Center For Cellular Immunotherapy)

    University Of Pennsylvania
    Remote - Europe

    Medical Device Clinical Trial Consultant

    Beacon Hill
    Remote, USA

    Associate Director, Clinical Trial Liaison (Field Based)

    Vertex Pharmaceuticals
    Remote, USA

    Post-Doctoral Fellow - 34229

    University Hospitals
    Denver

    Document Technician

    Open Systems Technologies
    Remote, USA

    Associate Direct/Director, Clinical Operations

    Orchestra Biomed
    Remote, USA

    Clinical Trials Project Manager Ii - Remote

    Cpc Clinical Research
    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 | Remote, USA | Switzerland |

    Makkah :

    Riyadh | Rabigh | Najran | Khulais | Jeddah |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |