Instagram
youtube
Facebook

Pspm Support Associate

3+ years
Preferred by Comapny
11 Nov. 24, 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

Job Title: Safety Support Specialist
Location: São Paulo, Brazil
Time Type: Full-Time
 

About Fortrea

Fortrea is a leading global contract research organization (CRO), providing clinical development, patient access, and technology solutions across over 20 therapeutic areas. With operations in more than 90 countries, we are committed to transforming drug and device development to improve the lives of patients worldwide.

Position Overview

We are looking for a Safety Support Specialist to join our team and support the set-up, maintenance, and close-out of global and regional clinical trials or post-marketing studies. This role involves supporting the Global Safety lead in various tasks, including the preparation of safety management plans, training materials, and safety-specific documentation, as well as assisting in the maintenance of safety databases and ensuring compliance with safety reporting regulations.

Main Responsibilities

  • Assist with the set-up, maintenance, and close-out of global or regional clinical trials and post-marketing studies.
  • Support the Global Safety lead in the preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-related documents.
  • Help in creating study-specific job aids, training materials, and templates.
  • Assist with systems set-up and ongoing maintenance during study start-up.
  • Provide support with functional management tasks, including access requests and training assignments.
  • Assist with the reconciliation of safety databases when required.
  • Draft, modify, and deliver safety presentations for both internal and external stakeholders.
  • Help generate monthly status reports and project-specific reports, ensuring the accuracy and quality of data.
  • Assist in Trial Master File (TMF) management activities as needed.
  • Support the preparation of safety documentation for internal, client, or regulatory audits.
  • Maintain a thorough understanding of Fortrea’s Standard Operating Procedures (SOPs) and other relevant documents.
  • Ensure compliant safety reporting according to US and international regulations, SOPs, and safety guidelines.
  • Demonstrate role-specific competencies and company values consistently.

Qualifications

  • Education: Bachelor's degree in a relevant field (e.g., life sciences, healthcare, etc.).
  • Experience:
    • Prior experience in safety support within clinical trials, pharmacovigilance, or a related field.
    • Familiarity with safety database management and clinical trial processes is a plus.
  • Skills:
    • Strong organizational skills and attention to detail.
    • Proficient in English (written and verbal).
    • Ability to collaborate with internal and external teams.
    • Knowledge of safety reporting regulations and guidelines.

Why Fortrea?

At Fortrea, we are committed to revolutionizing the development process of clinical trials and ensuring the swift delivery of life-changing therapies. We offer a collaborative work environment that nurtures personal and professional growth, allowing you to make a meaningful global impact.


Fortrea is an Equal Opportunity Employer
Fortrea is committed to diversity and inclusion and does not tolerate harassment or discrimination. Employment decisions are based on business needs and the qualifications of the individual. We encourage all qualified applicants to apply.

For more information on how we collect and store your personal data, please refer to our Privacy Statement.

Latest Jobs

Senior Medical Writer (Redaction)

Syneos Health
Gurugram

Safety & Pv Ops Specialist Ii - Technology Support (Argus Console Or Veeva Safety Preferred)

Syneos Health
Remote

Senior Medical Writer

Syneos Health
Remote

Senior Medical Writer

Syneos Health
Gurugram

Medical Writer Ii (Csr Narratives)

Syneos Health
Remote

Medical Writer Ii (Csr Narratives)

Syneos Health
Gurugram

Senior Medical Writer (Ctt & Redaction)

Syneos Health
Remote

Senior Medical Writer (Ctt & Redaction)

Syneos Health
Gurugram

Medical Writer Ii (Csr Narratives)

Syneos Health
Aachen Abbott Park Aberdeen Abilene Adelanto Ahmedabad Airoli Alameda Albany Albion Albuquerque Almaty Ambala Ambernath Ambler Amravati Amsterdam Anakapali Anantapur Anchorage Andover Ankleshwar Annamalainagar Appleton Arcata Argentina Arizona Arkansas Arlington Athens Atherton Atlanta Auckland Augusta Aurangabad Austin Australia Austria B.G Nagara Baddi Ballina Ballydine Baltimore Banasthali Bangalore Bangkok Bangor Barcelona Baroda Barrow Basel Basking Ridge Batavia Bathinda Baton Rouge Bavaria Bayreuth Be'Er Sheva Beijing Bel Air Bela Belgaum Belgium Belgrade Bellevue Bend Bengaluru Berkeley Berlin Bethel Bethlehem Bharuch Bhimavaram Bhiwadi Bhopal Bhubaneswar Biberach an der Riß Biddle Bielefeld Big Piney Bilaspur Billerica Birmingham Bishop Blacksburg Bloomfield Bloomingdale Bloomington Blue Ash Blue Bell Boca Raton Bochum Boerne Bogota Boise Bommasandra Bonn Boston Bothell Boulder Bountiful Branchburg Township Brazil Breda Brenham Brentwood Brewer Bridgeport Bridgewater Brinny Brisbane Bristol Brooklyn Brooksville Brunswick Brussels Bucharest Budapest Buenos Aires Buffalo Buffalo Grove Bulgaria Bulverde Burlingame Burlington Burney Cairo California Cambridge Canada Carlow Carlsbad Carolina Beach Carrollton Castlebar Cebu City Cedar Hill Champaign Chandigarh Chandler Chapel Hills Charleston Charlotte Charlottesville Chengdu Chennai Chessington Cheverly Chicago China Chittoor Cincinnati Ciudad de México Clark Clayton Clearwater Cleveland Coimbatore Cokeville Collegeville Cologne Colorado Columbia Columbus, Concord Cooper City Copenhagen Coquille Coral Gables Coral Springs Cork Corpus Christi Corsicana Corvallis Cranbury Crescent City Croatia Czech Republic Dalian Dallas Darmstadt Davis Dayton Daytona Beach Deerfield Dehradun Delhi Denmark Denton Denver Detroit Devens Dewas Dhule Dibrugarh Diburghar Dickinson Digha Dombivali Donegal Dortmund Downers Grove Downey Dubai Dublin Duisburg Duluth Dún Laoghaire Dunboyne Dunellen Durham Dusseldorf East Brunswick Eden Prairie Edgewood Edison El Monte El Paso El Segundo Elkridge Emeryville Enfield England Eot Municipality Erie Erlangen Erode Estonia Eugene Eureka Evendale Fairfield fairmont Falls Church Far Hills Faridabad Farmington Finland Flemington Florence Florida Fort Smith Fort Worth Fortuna Foster City France Frank Scottile Blvd Frankfurt Franklin Freiburg Fremont French Friday Harbor Fridley Ft MItchell Fulton Gainesville Gaithersburg Gajraula Galway Gandhinagar Garden city Garland Gautam buddha Nagar Georgia Germany GErmany Ghaziabad Glendale Glenview Goa Goldendale Gorakhpur Gottingen Grants Pass Greater Noida Greece Green Way Grenzach Groton Gujarat Guntur Gurgaon Gurugram Guwahati Gwalior Hà Nội Haarlem Hackensack Hajipur Halifax Halle Halol Hamburg Hamilton Hammond Hangzhou Hannover Hanoi Hanumakonda Harlow Harrisburg Harrogate Hartford Harveysburg Haryana Hauppauge Hawai Hawthorne Hayward Hebron Heidelberg Heist op den Berg Hibbing Hicksville Hilo Hisar Ho Chi Minh City Holly Springs Hollywood Honolulu Hoopa Hopewell Houghton Lake Houston Huber Heights Hungary Hyderabad India Indianapolis Indore Ingelheim am Rhein Ireland Irvine Istanbul Italy Ithaca Jacksonville Jaipur Jakarta Jalgaon Japan Jeddah Jersey City Jhagadia Jhansi John Day Juneau Kannur Kansas City Karlsruhe Karnataka Keene Kenosha kentucky Kfar Saba Khandwa Khargone Khulais Kiel King Abdullah Economic City Kingman Kings Mills Knoxville Kochi Kolhapur Kolkata Konstanz Koropi Kuala Lumpur Kurkumbh Kurla Kurukshetra Kyiv La Jolla Lake Charles Lake Forest Lake Havasu City Lake Oswego Lakeview Lakeway Lancaster Largo Larne Las Vegas Latvia Lawrence Lebanon Leeds Leiden Leinster Leipzig Lendava Lenexa Leuven Lexington Lima Limerick Linden Linthicum Lisbon Livingston Lombard London Longview Los Angeles Louisville Lousiana Lucknow ludhiana Lumberton Lyndhurst Lyon Macedonia Macomb Macon Madhapur Madison Madrid Madurai Mahabubnagar Mahwah Maidenhead Mainz Maitland Malappuram Malaysia Manchester Mangalagiri Mangaluru Manila Manipal Maple Grove Marburg Marietta Marsa Martinez Mason Massachusetts Mathura Mcallen McFarland McKinleyville McPherson Mechanicsville Medak Medan Medford and Somerville Mehsana Melbourne Memphis Menlo Park Mesa Mexico Miami Michigan Middleburgh Middletown Midrand Milan Milford Millbrae Milpitas Minneapolis and St. Paul, Minnesota. Minnesota Minnetonka Mississauga Mitte Moga Mohali Monmouth Junction Monroe Montgomery Montreal Montville Morgan Hill Morningside Heights Morrisville Mount Arlington Mount Vernon Mountain View Mt. Pleasant Mukundapur Mumbai Munich Munster Mysore Nagercoil Nagpur Nainital Nairobi Najran Naperville Naples Narsapur Nashik Nashville Navi Mumbai Nebraska City Nedlands Nellore Netanya Netherlands Nevada New Brunswick New Delhi New Hampshire New Haven New Jersy New Orleans New York New Zealand Newark Newtown Niš Noida Norridge North Carolina North Miami Beach North Richland Hills North York Norway NOrway Norwood Novato Nutley Oakland Oeiras OH Oklahoma City Ooty Orange Oregoina Orlando Osaka Otemachi Oulu oxford Pacheco Palo Alto PAN-India Panaji Panchkula Paramus Paris Park City Park RIdge Parsippany Pasadena Passaic Paterson Patiala Patna Peapack-Gladstone Pearl River Pembroke Pines Peridot Peru Phagwara Philadelphia Philippines Phoenix Piedmont Pilani Pine Brook Pirbright Piscataway Township Pithampur Pittsburgh Plainsboro Plano Plantation Pleasant Prairie Pleasanton Plymouth Meeting Poland Pomona Pondicherry (Puducherry) Port St. Lucie Portage Portland Portugal Pottstown Poughkeepsie Prague Prayagraj Princeton Junction Pudupakkam Pullman Pune Pune city Pydibimavaram Quarry Bay Queensland Rabigh Radnor Rahway Raipur Rajpura Raleigh Ranchi Rangareddy Rangpo Raritan Redding Redwood City Reedsport Regensburg Remote Remote - Africa Remote - Europe Remote - Middle East Remote - South America (Latin Americal) Remote Australia Remote Korea Remote, USA Renfrew Rensselaer Rhinebeck Rho Richardson Richmond Hill Riga Ringaskiddy Rishikesh Riverside Riyadh Rockland Rockville Rocky Mount Rohtak Romania Rome Roorkee Roseburg Roseville Rostock Round Lake Rourkela Rueil-Malmaison Runcorn Saarbrucken Sacramento Saint Petersburg Saitama Salem Salisbury Salt Lake City San Antonio San Bernardino San Carlos San Diego San Francisco San Gabriel San Jose San Juan San Mateo San Rafael Sanford Santa Clara Santa Cruz Santa Fe Santa Monica Santiago Sao paulo Sarajevo Sarasota Satyamev Scottsdale Seattle Seguin Sellersville Seoul Serbia Shanghai Shi Sheffield Shelbyville Sherwood Shirpur Shivalik Shreveport Siliguri Simi Valley Singapore Sitka Slovakia Slovenia Sofia Solan Soledad Somerset Somerville South Africa South Plainfield South San Francisco South Windsor South Yarra Southampton Southfield Spain Sparta Spring House Springfield Springville Srivilliputtur St. Helena St. Louis St.Paul Stamford Stanford Stanton Stevenage Stirling Stockton Storrs Stuart Stuttgart Summit Sunnyvale Surabaya Surprise Sweden Switzerland Swords Sydney Sylmar Syracuse Tacoma Taipei Tallahassee Tallinn Tampa Tandalja Tarapur Tarasadi Tartu Tel Aviv Temecula Tempe Texas Thailand Thane Thiruvananthapuram Thousand Oaks Tiruchirappalli Tirupathi Titusville Tokyo Tonopah Tonopsh Towson Trenton Trichy Trivandrum Tubingen Tucson Tucumcari Tulsa Turkey Turku Tuscaloosa Tyler Udaipur Udupi Ujjain Ulm United Kingdom United States Upper Marlboro Utica Uxbridge Vadodara Valencia Vallejo Vancouver Vapi Varanasi Vedant Vellore Venica Verna Victoria Vienna Vietnam Vijayawada Vikhroli Virginia Visakhapatnam Waco Warren Grove Warsaw Washington Waterford Watertown Waukesha Wausau Wavre Waynesville Welwyn West Chester West Hartford West Lafayette West Orange West Palm Beach West Sacramento West Valley City Westfield Westminster Wharton Whippany White Plains Whitesboro Whittier Willits Wilmington Winston-Salem Winter Haven Witney Woodburn Woonsocket Wrangell Wuhan Wurzburg Wyomissing Xzagreb Yavne Yerawada Yogyakarta Yuma Zagreb Zaragoza Zaventem Zurich

Senior Medical Writer (Ctt & Redaction)

Syneos Health
Remote