Instagram
youtube
Facebook

Associate Director, Global Drug Safety & Pv Scientist

4-11 years
$142,500.00---$237,500.00
10 July 4, 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 Description

Job Title: Associate Director of Drug Safety and Pharmacovigilance Scientist
Location: Princeton, NJ
Company: Genmab

Overview

At Genmab, we are committed to building extraordinary futures by developing innovative antibody products and pioneering therapies that transform the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We value being unique, striving to be our best, and maintaining authenticity to fulfill our purpose.

Genmab is on an ambitious growth path, and to support this, we are seeking an Associate Director of Drug Safety and Pharmacovigilance Scientist to join our team in Princeton. In this role, you will be part of the Global Drug Safety and Pharmacovigilance department, responsible for drug-related activities in close cooperation with Safety colleagues and cross-functional team members. This position has a global perspective and involves interaction with stakeholders, including regulatory authorities and colleagues from Genmab’s four sites. You will report to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead.

Responsibilities

  • Perform safety review of Adverse Event reports for Genmab products.
  • Conduct ongoing surveillance, including signal detection and evaluation, of clinical trials and post-marketing safety data.
  • Serve as the primary safety contact for other departments and ensure timely handling of safety issues.
  • Provide safety review and input for various documents, including Trial Protocols, eCRFs/CRFs, and TMFs.
  • Contribute to the development of Investigator’s Brochures and Subject Informed Consent documents.
  • Assist with HA requests and review key submission documents.
  • Develop safety-related documents throughout the product lifecycle, including monthly safety surveillance reports, Safety Assessment Reports, Aggregate Safety Reports (e.g., DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc safety information requests.
  • Participate in Safety Committee activities and DMCs.
  • Conduct safety training for Genmab employees, CROs, Investigators, and relevant site personnel.
  • Contribute to multidisciplinary project groups, including the Clinical Management Team (CMT) for assigned products.
  • Collaborate with safety and clinical CROs, oversee safety-related tasks, process invoices, and ensure regulatory compliance for assigned products.
  • Support the review of Safety Data Exchange Agreements with partners.
  • Collaborate with external experts and partners.
  • Stay updated on new and revised regulations/guidelines and assess their impact on drug safety processes.
  • Ensure compliance with regulatory guidelines and internal processes in preparation for audits and inspections.
  • Participate in audit and inspection activities as needed.
  • Perform other duties as assigned.

Requirements

  • Required: Health Care Professional degree (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years of experience in the pharmaceutical industry in drug safety and pharmacovigilance as a Safety Scientist.
  • Preferred: Experience in oncology and/or first human trials.
  • Experience authoring safety signal assessment reports, DSURs, PBRERs, RMPs, and RSIs.
  • Skilled in the signal detection process and managing safety information from clinical development and post-marketing sources.
  • Familiarity with FDA/EMA regulations and ICH guidelines governing pharmacovigilance and risk management.
  • Knowledge of drug development processes, pharmacovigilance databases, and MedDRA coding.
  • Experience with safety databases, preferably Argus Safety Database.
  • Proven experience overseeing multiple trials with safety inputs at the global level.
  • International experience with internal and external stakeholders.
  • Excellent communication skills in English, both written and spoken.

Personal Attributes

  • Strong communicator with excellent relationship-building skills.
  • Proactive and able to prioritize work in a fast-paced, changing environment.
  • Result- and goal-oriented with a commitment to contributing to Genmab’s success.
  • Determined to do and be your best and take pride in enabling the best work of others.
  • Not afraid to grapple with the unknown and be innovative.
  • Experience working in a fast-growing, dynamic company is preferred.

Compensation

  • Salary Range: $142,500.00 - $237,500.00
  • The actual salary offer will consider various factors, including skills, qualifications, experience, and location. Certain positions may be eligible for additional forms of compensation, such as bonuses.

About Genmab

Genmab is an international biotechnology company with a core purpose of improving patients' lives through innovative and differentiated antibody therapeutics. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan. Our team is passionate, innovative, and collaborative, leveraging next-generation antibody technology platforms and translational research and data sciences to develop novel therapies. We have formed over 20 strategic partnerships with biotechnology and pharmaceutical companies to help deliver these therapies to patients.

Commitment to Diversity, Equity, and Inclusion

Genmab is dedicated to fostering workplace diversity at all levels of the company, believing it is essential for our continued success. We provide equal employment opportunities to all applicants without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

Application Process

To apply, please visit our website and submit your application. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for details on how we handle your data in connection with your application.

Additional Information for Netherlands-Based Applicants

For permanently budgeted hires in the Netherlands, Genmab’s policy is to initially offer a fixed-term employment contract for a year. If the employee performs well and business conditions remain favorable, renewal for an indefinite term may be considered.

For more information about Genmab and to view our privacy policy, please visit Genmab.

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