• Login / Signup
    • Instagram
    youtube
    Facebook

    Drug Safety Reporting Senior

    Thermo Fisher Scientific
    8+ years
    Not Disclosed
    Remote, USA
    12 May 21, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Safety Reporting Project Manager

    Company: Thermo Fisher Scientific

    Location: Remote

    About Us:

    At Thermo Fisher Scientific, we empower our employees to make a global impact. Our mission is to enable our customers to make the world healthier, cleaner, and safer. Our work spans laboratory, digital, and decentralized clinical trial services, driven by our PPD clinical research portfolio. Join us in improving health outcomes worldwide.

    Job Purpose:

    The Safety Reporting Project Manager is responsible for planning, coordinating, and delivering safety reporting for large and complex projects. This role involves full project oversight, including metrics, compliance, and finances. The Project Manager will provide training and support to team members and serve as the primary point of contact in the absence of the manager.

    Key Responsibilities:

    • Safety Reporting:

      • Receive, prepare, and submit safety reports to applicable parties, ensuring compliance at all stages.
      • Identify and resolve quality or timeline issues, keeping the manager informed of progress.
      • Lead and monitor large, complex projects to ensure successful and timely completion.

    • Project Management:

      • Develop project plans and manage timelines for safety reporting.
      • Recommend updates to procedures and participate in regulatory intelligence activities.
      • Attend and present at various meetings as required.

    • Team Support:

      • Provide training and support to lower-level team members.
      • Mentor new starters and provide input on individual performance.
      • Facilitate and advise on company, client, and regulatory audits as needed.

    • Reporting and Metrics:

      • Work with the manager to collate metrics and analyze compliance.
      • Provide recommendations on updating financial systems.

    Qualifications:

    • Education:

      • Bachelor's degree in a relevant field.

    • Experience:

      • Minimum of 8 years of relevant experience or an equivalent combination of education, training, and experience.

    • Skills and Abilities:

      • Advanced knowledge of medical terminology.
      • Excellent Microsoft Office skills and understanding of database functionality.
      • Thorough understanding of global safety reporting requirements.
      • Strong critical thinking and problem-solving abilities.
      • Demonstrated leadership, mentoring, and motivational skills.
      • Strong attention to detail and ability to work with ambiguity.
      • Ability to work collaboratively within a team environment.
      • Excellent communication, persuasion, and negotiation skills.

    Why Thermo Fisher Scientific:

    • Join a team of over 100,000 colleagues united by common values: Integrity, Intensity, Innovation, and Involvement.
    • We offer diverse experiences, backgrounds, and perspectives, working together to accelerate research, solve scientific challenges, drive technological innovation, and support patients in need.

    Application Information:

    • Apply today
    • Thermo Fisher Scientific is an EEO/Affirmative Action Employer.

    Accessibility/Disability Access:

    • If you require accessibility assistance or an accommodation to apply, please call 1-855-471-2255*. Include your contact information and specific details about your required accommodation.

    Contact:

    *This telephone line is reserved for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes will not receive a response.

    Latest Jobs

    Clinical Research Scientist

    Insmed
    Remote, USA

    Senior Clinical Data Manager

    Insmed
    Bridgewater

    Clinical Document Specialist, Clinical Documentation Management

    Rwj Barnabas Health
    Livingston

    Clinical Document Specialist, Clinical Documentation Management

    Rwj Barnabas Health
    Livingston

    Clinical Research Associate Ii

    Syneos Health
    Remote, USA

    Clinical Research Associate

    Syneos Health
    Remote - Europe

    Senior Clinical Research Associate Ii

    Syneos Health
    Remote - Europe

    Medical Information And Adverse Event Intake Specialist

    Iqvia
    Solan

    Scientific Specialist

    Parexel
    Remote

    Pharmacovigilance (Qppv)

    Parexel
    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 | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | 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 :

    Kochi | Malappuram |

    Madhya Pradesh :

    Indore |

    Maharashtra :

    Amravati | Aurangabad | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | 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 :

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

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata |

    Pharma Jobs in United States

    Arizona :

    Chandler | Tempe | Tucson |

    California :

    Davis | Emeryville | Foster City | La Jolla | Los Angeles | Pasadena | Riverside | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Stanford |

    Colorado :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Tallahassee |

    Georgia :

    Atlanta |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    Maryland :

    Baltimore | 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 | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Warren Grove | West Orange | Westfield | Whippany |

    New York :

    Buffalo | Ithaca | Morningside Heights |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Raleigh |

    Ohio :

    Columbus, |

    Pennsylvania :

    Philadelphia | Pittsburgh |

    Tennessee :

    Nashville |

    Texas :

    Austin | Houston |

    Virginia :

    Blacksburg |

    Washington :

    Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    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 Australia & England & Europe & Ireland & Remote & Saudi Arabia

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    United Kingdom :

    London |

    Serbia :

    Belgrade |

    Republic of Ireland :

    Dublin | Limerick |

    Remote :

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

    Makkah :

    Najran | Jeddah |