• Login / Signup
    • Instagram
    youtube
    Facebook

    Safety Surveillance Associate

    Pfizer
    2+ years
    Not Disclosed
    Philadelphia Philippines
    10 Nov. 13, 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

    Position Title: Associate – Pharmacovigilance
    Location: Hybrid
    Reports To: Pharmacovigilance Manager

    Why Patients Need You

    Pfizer Worldwide Medical and Safety colleagues are instrumental in providing evidence-based medical decision support, ensuring the safe and appropriate use of medicines. Our mission is to empower healthcare decisions, ensuring better health outcomes for patients by providing scientifically sound frameworks, unbiased medical expertise, and investigating data gaps.

    What You Will Achieve

    As an Associate, you will contribute to monitoring Pfizer's drug, biologics, and medical device surveillance programs. This includes evaluating, processing, and reporting adverse events, supporting clinical trials, and post-marketing activities. Your commitment and domain knowledge will foster a collaborative environment, helping the team achieve project milestones and goals. Your dedication will ensure that Pfizer’s customers and patients receive the medicines they need, when they need them.

    How You Will Achieve It

    • Contribute to the completion of project milestones by organizing your work to meet deadlines.
    • Provide expertise to project teams on regulatory requirements and corporate policies governing regulatory submissions.
    • Support Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data, reviewing medical literature, and assisting with related activities.
    • Review case criteria to determine appropriate workflows for case processing.
    • Write, edit, and review adverse event case narratives.
    • Generate reports while ensuring adherence to regulatory compliance timelines.
    • Perform appropriate case follow-up, including generating and requesting follow-up letters.
    • Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders, to ensure safety data collection and reconciliation.

    Position Purpose

    The role involves reviewing, preparing, and completing reports on adverse drug experiences, determining the safety profile of Pfizer’s products, and ensuring compliance with regulatory requirements.

    Responsibilities

    • Identify and select routine cases for processing, prioritize based on set criteria, and note any delays.
    • Assess cases to identify those with complexities or specific issues, escalating them appropriately.
    • Process and document event terms, case classifications (validity, seriousness, expectedness, listedness), special scenarios, product complaints, reportability with due dates, and ensure accuracy and consistency.
    • Write and edit case narratives based on assessments.
    • Ensure compliance with regulatory timelines while generating reports.
    • Collaborate with internal and external partners to facilitate safety data collection and data reconciliation.
    • Maintain expertise in assigned products, applicable global regulations, guidelines, and Pfizer policies.
    • Consistently apply regulatory requirements and Pfizer’s policies across all processes.

    Qualifications

    Must-Have

    • Bachelor’s degree in a science-related field (Pharmacy, Nursing, etc.)
    • Healthcare professional qualification required
    • Ability to solve routine problems with supervision and raise issues constructively
    • Basic decision-making abilities with an understanding of consequences
    • Fluency in spoken and written English

    Technical Skills

    • Experience in pharmacovigilance, clinical care, or clinical/scientific research is advantageous but not required
    • Proficiency in computer systems and relational databases
    • Ability to meet personal objectives while adhering to departmental performance standards
    • Ability to work effectively in a matrix organization
    • Excellent oral and written communication skills
    • Experience with medical writing is an advantage

    Work Location

    Hybrid

    Equal Employment Opportunity

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

     

     

     

     

    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, USA | Remote - Europe | Remote | Switzerland |

    Makkah :

    Rabigh | Riyadh | Khulais | Najran | Jeddah |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |