Current jobs related to Senior Manager, Pharmacovigilance - Jersey City - Eikon Therapeutics
-
Senior Pharmacovigilance Expert
2 weeks ago
Jersey City, New Jersey, United States YD Talent Solutions Full timeJob OverviewYD Talent Solutions is seeking a highly skilled Pharmacovigilance Expert to join our team. As a key member of our client's Pharmacovigilance team, you will be responsible for ensuring the safe and effective use of our client's products.Key ResponsibilitiesProvide expert guidance on Pharmacovigilance principles and practices.Collaborate with...
-
Senior Pharmacovigilance Director
6 days ago
Jersey City, New Jersey, United States YD Talent Solutions Full timeAbout Our Company:YD Talent Solutions is a leading provider of Pharmacovigilance Technology Solutions. Our team brings deep expertise in drug safety paired with advanced technology including AI and GenAI. Our innovative solutions tackle the most pressing challenges in the pharmaceutical industry. These solutions drive both operational efficiency and enhanced...
-
Senior Pharmacovigilance Director
2 weeks ago
Jersey City, New Jersey, United States YD Talent Solutions Full timeAbout Our ClientOur client is a leading provider of innovative Pharmacovigilance Technology Solutions. They bring deep expertise in drug safety paired with advanced technology, including AI and GenAI. Their solutions tackle the most pressing challenges in the pharmaceutical industry, driving both operational efficiency and enhanced business performance.Their...
-
Senior Pharmacovigilance Systems Specialist
2 weeks ago
Jersey City, New Jersey, United States YD Talent Solutions Full timeJob DescriptionAbout our client:Our client is a leading provider of pharmacovigilance solutions, leveraging advanced technologies to develop agile, flexible, and scalable systems that address challenges across Medical Affairs, Regulatory, and Safety functions.Their solutions enable pharmaceutical companies to free up responsible personnel, execute their...
-
Pharmacovigilance Expert
2 weeks ago
Jersey City, New Jersey, United States YD Talent Solutions Full timeAbout our client:Our client is a leading provider of Pharmacovigilance solutions, leveraging advanced technologies to develop agile, flexible, and scalable systems that address challenges across Medical Affairs, Regulatory, and Safety functions. Their expertise enables Pharma companies to execute their responsibilities while maintaining compliance and...
-
Pharmacovigilance Operations Manager
2 weeks ago
Oklahoma City, Oklahoma, United States Sumitomo Pharma Full timeJob Title: Manager, CTSAJob Summary:Sumitomo Pharma America is seeking a highly motivated and experienced Manager, CTSA to join our team. The successful candidate will be responsible for managing Pharmacovigilance (PVRM) and non-PVRM vendors, ensuring compliance with regulatory requirements and company policies.Key Responsibilities:Manage PVRM vendors to...
-
Project Manager
6 days ago
Jersey City, New Jersey, United States YD Talent Solutions Full timeAbout our company:YD Talent Solutions is a leading provider of top talent in the life sciences industry. We bring deep expertise in pharmacovigilance technology solutions, paired with advanced technology, including AI and GenAI. Our innovative solutions tackle the most pressing challenges in the pharmaceutical industry, driving both operational efficiency...
-
Jersey City, New Jersey, United States AbbVie Full timeAt AbbVie, we are committed to delivering innovative medicines and solutions that address serious health issues. As a key member of our team, you will play a critical role in ensuring the safety of our late-stage and post-marketing hematology-oncology portfolio.Key Responsibilities:Manage a team of Associate Medical Directors, Medical Directors, and Senior...
-
Director, Pharmacovigilance
1 month ago
New York City, United States ClinChoice Full timeDirector, Pharmacovigilance (PV) Clinical Trials Operations at ClinChoice (View all jobs) United States Location: United States - Homebased Schedule: Permanent- FTE ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We...
-
Drug Safety Data Manager
2 weeks ago
Jersey City, New Jersey, United States Mitsubishi Tanabe Pharma Full timeJob Title: Manager, Drug Safety DataAt Mitsubishi Tanabe Pharma America, we are seeking a highly skilled and experienced Manager, Drug Safety Data to join our team. As a key member of our pharmacovigilance department, you will be responsible for managing and analyzing safety data to ensure the safety of our pharmaceutical products.Key...
-
Pharmaceutical Safety Data Manager
2 weeks ago
Jersey City, New Jersey, United States Mitsubishi Tanabe Pharma Full timeJob SummaryMitsubishi Tanabe Pharma America is seeking a highly skilled Pharmaceutical Safety Data Manager to join our team. As a key member of our pharmacovigilance department, you will be responsible for managing and analyzing safety data to ensure the safety of our pharmaceutical products.Key ResponsibilitiesOversee the collection, processing, and...
-
Project Manager
2 weeks ago
Jersey City, New Jersey, United States YD Talent Solutions Full timeAbout Our ClientYD Talent Solutions is a leading provider of innovative solutions for the life sciences industry. Our client is a renowned company that brings deep expertise in Pharmacovigilance Technology Solutions, paired with advanced technology, including AI and GenAI.They offer a range of proprietary products and services, including automated case...
-
Senior Medical Director, Late Stage Oncology
6 days ago
Jersey City, New Jersey, United States AbbVie Full timeJob Summary:AbbVie is seeking a highly skilled and experienced Medical Director to lead our Late Stage Oncology team. As a key member of our Pharmacovigilance and Clinical Development team, you will be responsible for ensuring the safety of our hematology-oncology portfolio.Key Responsibilities:Manage and lead cross-functional teams to ensure the safety of...
-
Business Development Director
2 weeks ago
Jersey City, New Jersey, United States RxLogix Full timeJob SummaryRxLogix Corporation Ltd is seeking a seasoned Business Development Director to spearhead the growth of our consulting sales, specifically targeting opportunities that follow SaaS license sales.This role will focus on driving sales related to our pharmacovigilance software, encompassing initial implementation, consulting, managed services, and...
-
Senior Clinical Research Scientist
2 weeks ago
Jersey City, New Jersey, United States ICON Strategic Solutions Full timeJob Title: 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...
-
Project Manager
3 weeks ago
Jersey City, New Jersey, United States YD Talent Solutions Full timeAbout Our ClientYD Talent Solutions is a leading provider of innovative solutions for the life sciences industry. Our team has decades of experience in engineering and deploying best-in-class solutions, with a proven track record of scaling operations globally in line with business demands.Job DescriptionWe are seeking a highly skilled Project Manager to...
-
Quality Assurance Specialist
2 weeks ago
Jersey City, New Jersey, United States eTeam Full timeJob Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at eTeam. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our Pharmacovigilance (PV) operations.Key Responsibilities:Perform reviews of individual case safety report compliance...
-
Quality Assurance Specialist
2 weeks ago
Jersey City, New Jersey, United States eTeam Full timeJob Title: Quality SpecialistJoin eTeam as a Quality Specialist and contribute to the success of our organization by ensuring the highest quality and compliance in our Pharmacovigilance operations.About the Role:Under the direction of the PV Quality and Compliance Associate Director, this role will be responsible for performing reviews of individual case...
-
Quality Specialist
4 weeks ago
Jersey City, United States eTeam Full timeQuality Specialist - II (Associate) Jersey City, NJ- 100% remote role. 3 Months extendable contract Pay : $45.86/hr Under the direction and oversight of the PV Quality and Compliance Associate Director, this role will: • Perform reviews of individual case safety report compliance monitoring outputs to ensure high quality and compliant reporting in...
-
Quality Specialist
2 months ago
Jersey City, United States Eteam Remote Work Freelance Full timeQuality Specialist - II (Associate) Jersey City, NJ- 100% remote role. 3 Months extendable contract Pay : $45.86/hrUnder the direction and oversight of the PV Quality and Compliance Associate Director, this role will: • Perform reviews of individual case safety report compliance monitoring outputs to ensure high quality and compliant reporting in...
Senior Manager, Pharmacovigilance
2 months ago
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
We are seeking an experienced Senior Manager, Pharmacovigilance to join our team. The Senior Manager, Pharmacovigilance will be responsible for the management of safety data across our portfolio of products. The successful candidate will play a critical role in ensuring the safety of our patients by proactively monitoring and assessing adverse events, as well as working cross-functionally to ensure compliance with regulatory requirements. This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in our New Jersey office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You are a Pharmacovigilance expert with a passion for drug discovery. You are an analytical, detail-oriented, and you have an appreciation for compliance. You’re collaborative by nature with uncompromising integrity. You’re conscientious and pay almost obsessive attention to detail, documentation and organization are second nature. You are a self starter in spirit.
What You’ll Do
Lead and manage pharmacovigilance activities for our clinical-stage programs. Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams to ensure the safety of our products. Oversee the development and maintenance of pharmacovigilance processes and procedures. Manage safety data collection, processing, evaluation, and reporting in compliance with applicable regulations and guidelines. Contribute to the preparation and review of safety sections of regulatory submissions. Conduct safety surveillance activities, including signal detection (like performing analyses of safety information) and risk management. Coordinate and manage relationships with external vendors and partners involved in pharmacovigilance activities. Provide pharmacovigilance expertise and support for product development and lifecycle management activities.Qualifications:
Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations processes. MD is preferred. Strong understanding of global regulatory requirement related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.). Proven ability to lead and manage pharmacovigilance activities independently. Excellent communication skills and ability to collaborate effectively across multidisciplinary teams. Detail-oriented with strong analytical and problem-solving skills. Experience with safety databases and pharmacovigilance systems. Experience in oncology or rare diseases is a plus. Previous experience interacting with health authorities during inspections and audits.At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-siteThe expected salary range for this role is $161,000 to $175,750 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
