Director, Pharmacovigilance Scientist

3 weeks ago

New Providence, New Jersey, United States ADC Therapeutics Full time
Job Title: Director, Pharmacovigilance Scientist

ADC Therapeutics is seeking a highly skilled and experienced Director, Pharmacovigilance Scientist to join our Global Drug Safety function. As a key member of our team, you will play a critical role in supporting the safety strategy and requirements for our assigned drug project(s).

Main Responsibilities:
  • Lead PV Scientist activities of cross-functional project teams for developmental compounds and/or marketed products.
  • Work in collaboration with the Global Safety Physician (GSP) to develop, maintain, oversee, and execute the comprehensive safety surveillance and signal detection plan for assigned products.
  • Author and contribute safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents, and Clinical Study Reports.
  • Lead the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
  • Author/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
  • Author/provides strategic leadership to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
  • Contribute to pharmacovigilance and risk management planning for ADCT products, including preparation of the safety aspects of Risk Management Plans with the applicable License Partners as appropriate and REMS if applicable.
  • Support multidisciplinary SST and SMT and escalation of all relevant safety matters to the appropriate decision-making level, providing appropriate proposals for solutions based on analysis of the available information and in collaboration with the GSP.
Requirements:
  • Bachelor's in sciences/pharmacy/nursing degree or related field.
  • 8+ years of proven pharmacovigilance experience, preferably in oncology.
  • Patient Safety and/or Clinical/Drug Development with proven experience working in safety &/or scientific activities in at least 3 of the following areas: Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning), Post-Marketing Surveillance (including signal detection & evaluation), MAA/BLA (preparation and authoring of the safety related aspects of the Common Technical Document), Periodic Safety Reports (deliver strategy, preparation and authoring), Risk Management Plans (deliver strategy, preparation and authoring), Safety governance board interactions and communication across a range of activities.
  • Demonstrated ability to handle more than one activity simultaneously, prioritizing and recognizing key issues.
  • Ability to work effectively in an advanced matrix structure.
  • Proficient in expressive and receptive communications in English language.
  • Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI.
  • Skilled in signal detection process and managing safety information from clinical development and post-marketing sources.
  • Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.
  • Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding.
  • Experience with use of safety databases, preferably Argus Safety Database.
  • Documented experience in multiple trials with safety inputs at the Global level.
  • International experience from a similar role with internal and external stakeholders.

  • Director, Pharmacovigilance Scientist

    2 days ago

    New Providence, New Jersey, United States ADC Therapeutics SA Full time

    Job Title: Director, Pharmacovigilance ScientistADC Therapeutics SA is seeking a highly skilled and experienced Director, Pharmacovigilance Scientist to join our Global Drug Safety function. As a key member of our team, you will play a critical role in supporting the safety strategy and requirements for our assigned drug projects.Main Responsibilities:Lead...

  • Senior Pharmacovigilance Leader

    2 days ago

    New Providence, New Jersey, United States ADC Therapeutics America, Inc. Full time

    Job Title: Director, Pharmacovigilance ScientistWe are seeking a highly skilled and experienced Director, Pharmacovigilance Scientist, to join our team at ADC Therapeutics America, Inc. in our Global Drug Safety function.About the Role:In this challenging and exciting role, you will work collaboratively with the Global Safety Physician (GSP), other...

  • Senior Director, Head of Pharmacovigilance

    4 weeks ago

    New York, New York, United States Planet Pharma Full time

    Job Description:The Senior Director, Head of Pharmacovigilance will be responsible for establishing and leading the Pharmacovigilance function within Planet Pharma.This role will be pivotal in developing the strategy, systems, and processes necessary to ensure the safety of our assets throughout their lifecycle.Key Responsibilities:Develop and execute the...

  • Principal Director of Pharmacovigilance Solutions

    7 days ago

    New Brunswick, New Jersey, United States YD Talent Solutions Full time

    About Our ClientOur client is a pioneering provider of cutting-edge Pharmacovigilance Technology Solutions. They bring unparalleled expertise in drug safety, paired with innovative technologies, including AI and GenAI. Their forward-thinking solutions tackle the most pressing challenges in the pharmaceutical industry, driving both operational efficiency and...

  • Principal Director of Pharmacovigilance Solutions

    2 days ago

    New Brunswick, New Jersey, United States YD Talent Solutions Full time

    About Our ClientOur client is a pioneering provider of cutting-edge Pharmacovigilance Technology Solutions. They bring unparalleled expertise in drug safety, paired with innovative technology, including AI and GenAI. Their forward-thinking solutions tackle the most pressing challenges in the pharmaceutical industry, driving both operational efficiency and...

  • Clinical Scientist Lead

    3 weeks ago

    New York, New York, United States SciPro Full time

    Job Title: Associate Director Clinical ScientistWe are seeking a highly skilled Clinical Scientist to play a crucial role in scientific planning and collaboration with Clinical Research, Pharmacovigilance, and Clinical Operations teams in the execution of one or more clinical trials or significant components thereof.This position offers the opportunity to...

  • Senior Clinical Research Scientist

    3 weeks ago

    New York, New York, United States ICON Strategic Solutions Full time

    Senior Clinical ScientistAt ICON Strategic Solutions, we are seeking a highly skilled and experienced Senior Clinical Scientist to join our team. As a key member of our clinical research organization, you will be responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s).Key Responsibilities:Lead clinical/scientific...

  • Clinical Director of Scientific Operations

    2 days ago

    New York, New York, United States SciPro Inc. Full time

    SciPro Inc. Clinical Scientist OpportunityWe are seeking a highly skilled Clinical Scientist to play a crucial role in scientific planning and collaboration with Clinical Research, Pharmacovigilance, and Clinical Operations teams in the execution of one or more clinical trials or significant components thereof.This position offers the opportunity to showcase...

  • Clinical Development Director

    2 days ago

    New York, New York, United States Roivant Sciences Full time

    Job Title: Clinical Development DirectorThe Clinical Development Director will play a key role in the Clinical Development group at Roivant Sciences, providing clinical scientific leadership for programs and direct responsibility for clinical development strategy and execution of clinical trials, with a focus on immunology and rare...

  • Clinical Director, Oncology Therapeutic Area

    1 day ago

    New York, New York, United States Eikon Therapeutics Full time

    About Eikon TherapeuticsEikon Therapeutics is a pioneering biopharmaceutical company at the forefront of revolutionary technology that converges chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Our discovery platform is built on groundbreaking innovations from our founders, culminating in the...

  • Associate Director/Director, Quality Assurance

    4 weeks ago

    New York, New York, United States Larimar Therapeutics Full time

    About Larimar TherapeuticsLarimar Therapeutics Inc. is a clinical-stage biotechnology company focused on developing innovative treatments for complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp, is a subcutaneously administered, recombinant fusion protein designed to deliver human...

  • Clinical Research Scientist

    1 day ago

    New York, New York, United States Lifelancer Full time

    Job OpportunityWe are seeking a highly skilled Clinical Research Scientist to join our team at Lifelancer. As a key member of our clinical research team, you will contribute to the design, conduct, analysis, and reporting of clinical trials.Key Responsibilities:Collaborate with the VP of Clinical Development to review, interpret, and communicate scientific...

  • Clinical Scientist, Associate Director/Director

    4 weeks ago

    New York, New York, United States Ichnos Glenmark Innovation Full time

    Job SummaryWe are seeking an experienced Clinical Scientist to provide scientific leadership in the design, execution, and interpretation of clinical trials in oncology. The successful candidate will collaborate with Medical Directors and the Chief Medical Officer to develop and implement clinical trial strategies.Key ResponsibilitiesLead the development of...

  • Director of Materials Engineering and Crystallization

    3 weeks ago

    New Brunswick, New Jersey, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We are seeking a highly skilled and experienced Director of Materials Engineering and Crystallization to join our team.About the...

  • Director, Field HEOR Scientist

    2 weeks ago

    New York, New York, United States Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Director, Field HEOR Scientist to join our team.The successful candidate will be responsible for leading the clinical engagement with key access...

  • Medical Director

    2 weeks ago

    New York, New York, United States Memorial Sloan Kettering Cancer Center Full time

    Job Title: Director of Medical Staff ServicesAt Memorial Sloan Kettering Cancer Center, we are seeking a highly skilled and experienced Director of Medical Staff Services to lead our team of clinical investigators and researchers in the Leukemia Service of the Department of Medicine.About the RoleThe successful candidate will be responsible for leading the...

  • Data Science Director

    2 days ago

    New York, New York, United States Scholastic Full time

    Job Title: Director, Data ScienceAt Scholastic, we are seeking a visionary leader to spearhead our Data Science initiatives. As the Director of Data Science, you will be responsible for leading a team of data scientists to drive business growth, mitigate risks, and identify opportunities for innovation.Key Responsibilities:Develop and execute a data science...

  • Senior Director Medical Affairs

    2 weeks ago

    New York, New York, United States CSL Behring Full time

    Job Title: Senior Director Medical AffairsCSL Behring is seeking a highly experienced Senior Director Medical Affairs to lead our Inline Ig products. As a key member of our Medical Affairs team, you will provide strategic medical leadership and direction to our global organization.Main Responsibilities:Oversee and direct the activities of Medical Directors...

  • Data Scientist Director

    1 day ago

    New York, New York, United States Hispanic Technology Executive Council Full time

    Job DescriptionAs a Director of Data Science, you will play a key role in shaping our strategic direction and leading the execution of data-driven insights to enhance our digital products. You will utilize advanced machine learning and generative AI technologies to proactively identify customer needs and deliver actionable customer experiences to meet those...

  • Medical Safety Specialist

    3 weeks ago

    New York, New York, United States BioTalent Full time

    Medical Safety Scientist Job DescriptionJob Title: Medical Safety ScientistLocation: Fully Remote (East Coast +/- 1-2 hours)Hourly Rate: CompetitiveContract Type: 12-month ContractBioTalent is delighted to be partnered with a leading Pharmaceutical Manufacturing company and we are seeking a Medical Safety Scientist to join the team on a long-term contract...