• Login / Signup
    • Instagram
    youtube
    Facebook

    Pv Associate/Sr Pv Associate

    Icon
    1-5 years
    Not Disclosed
    Chennai
    15 June 10, 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, 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: Safety Review Specialist

    Responsibilities:

    1. Review and process safety events (pre-marketing, post-marketing, medical device, and drug) and/or other medically related information per assigned tasks and project-specific procedures.
    2. Perform review of abstracts and full articles to identify safety information from literature sources for both pre and post-marketed products.
    3. Generate data listings from the safety database and ensure the accuracy of the data.
    4. Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
    5. Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
    6. Perform safety review of clinical and diagnostic data as part of case processing.
    7. Develop the Safety Management Plan effectively, including specific processes to ensure consistency within the project.
    8. Support the creation of post-marketing safety activities, such as PSMF, RMP, and PBRER.
    9. Assist with identifying out-of-scope activities in conjunction with the Pharmacovigilance Project lead (as applicable).
    10. Attend project team and Sponsor meetings and teleconferences as required, including presentation of the safety process at kick-off and investigator meetings.
    11. Support the generation of Aggregated Safety Reports through data retrieval and other assigned tasks.
    12. Support interim data analysis for DMC reviews.
    13. Maintain the safety database and corresponding entry guidelines, including assurance of data quality following established quality control processes.
    14. Support creation of the SAE/AE reconciliation plan and support SAE reconciliation in accordance with this plan and other project-specific guidelines.
    15. Support Safety Scientist in signal detection and risk management activities.
    16. Propose solutions for procedural and technical issues.
    17. Support audits and inspections as required for the assigned projects.
    18. Perform other activities as identified and requested by management, including responding and processing medical information inquiries related to adverse events and product complaints for Clients' products.

    Requirements:

    • 1 years of experience in pharmaceutical industry/clinical research organization.
    • Proficient in [relevant software/tools].
    • Strong attention to detail and analytical skills.
    • Excellent communication and interpersonal abilities.

    Note: This vacancy has expired, but similar roles may be available.

    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 :

    Osaka | Tokyo |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    London | Salt Lake City |

    Republic of Ireland :

    Dublin | Limerick |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

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

    Makkah :

    Riyadh | Najran | Jeddah | Khulais | Rabigh |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |