Associate Director, Pharmacovigilance
3 weeks ago
The Associate Director of Pharmacovigilance will provide expert PV leadership to independently review and assess safety information from various sources. This includes evaluating medical content and leading the identification of potential safety signals at both the individual case and aggregate levels. The role involves taking the lead in safety activities and benefit-risk assessments for assigned programs, chairing Safety Surveillance Committees, and contributing significantly to Independent Data and Safety Monitoring Committees (DSMCs) meetings.
Qualifications:
- MD or equivalent required.
- Postgraduate qualification or experience in gene therapy, cell therapy clinical development, or a related specialty is preferred.
- At least 8 years of experience in pharmacovigilance.
- In-depth knowledge of pharmacovigilance processes and the ability to apply this expertise to evaluate safety concerns and minimize patient risk throughout the product lifecycle.
- Experience in the cardiovascular or rare disease is highly desirable.
Responsibilities:
- Lead safety activities and develop benefit-risk strategies for assigned programs, chairing program Safety Surveillance Committees and contributing to DSMC meetings for investigational products.
- Provide medical input and review of aggregate safety reports (PBRER, DSUR, 120-day safety updates), safety sections of clinical trial documents (such as protocols, clinical study reports, investigator brochures, informed consent forms), and regulatory submissions (clinical trial applications, marketing authorization applications).
- Serve as the medical expert in safety for assigned programs
- Prepare responses to safety-related queries from regulatory authorities as needed.
-
Senior/Lead MICC Associate
13 hours ago
Princeton, United States Navitas Life Sciences Full timeJob Description We are currently seeking experienced MICC professionals to join our growing team. Within the role you will: Be responsible for receiving calls and/or emails (AE, PQC, MI & GI), case intake, duplicate check, and registration. Carry out follow-up inquiries through phone and email, including the translation of the inquiry if not in a primary...
-
Executive Director, Head of Regulatory Affairs
6 hours ago
Princeton, United States PMV Pharmaceuticals, Inc Full timeExecutive Director, Head of Regulatory AffairsReports to: Chief Development OfficerLocation: Hybrid (2 days a week in Princeton, NJ office)The Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the company meets its objectives. The candidate will be responsible for working with global...
-
Associate Director, Clinical Operations
4 hours ago
Princeton, United States iuvo BioScience, llc. Full timePosition: Associate Director, Clinical Operations Company: Sun Pharma Advanced Research Company Limited Location: Princeton, New Jersey Summary The Associate Director, Clinical Operations is responsible for overseeing the Project Management team, Clinical Research Associates, and Clinical Trial Associates. This hybrid role involves motivating, mentoring, and...
-
Associate Director
3 weeks ago
Princeton, United States Y-mAbs Therapeutics, Inc. Full timeAssociate Director / Director, IT Business OperationsAre you ready to uplevel your career? Join an innovative biopharmaceutical company and be part of our exciting journey!We are looking for a Associate Director / Director, IT Business Operations to join our team.Working with UsAt Y-mAbs Therapeutics (NASDAQ: YMAB), our mission is to become the world leader...
-
Associate Director
1 week ago
Princeton, United States Y-mAbs Therapeutics, Inc. Full timeAssociate Director / Director, IT Business OperationsAre you ready to uplevel your career? Join an innovative biopharmaceutical company and be part of our exciting journey!We are looking for a Associate Director / Director, IT Business Operations to join our team.Working with UsAt Y-mAbs Therapeutics (NASDAQ: YMAB), our mission is to become the world leader...
-
Associate Director, Procurement Operations
3 months ago
Princeton, United States InsideHigherEd Full timeOverviewThe Associate Director, Procurement Operations reports to the Executive Director, Facilities Budget, Procurement & Analysis (FBPA), who is a direct report to the Assistant Vice President, Facilities Finance and Administrative Services. The Associate Director leads a team of eight (8) and has 2 direct reports. Reporting to this role is the Manager,...
-
Associate Creative Director, Art
2 months ago
Princeton, United States MRM Full timeMRM for Health is looking for a talented, collaborative Associate Creative Director, Art to join our growing team.This person will work hands on, on projects as well as lead the Creative team in producing a high-quality creative product for the agency’s clients. Along with the account service representatives, the Associate Creative Director maintains...
-
Associate Medical Director
3 weeks ago
Princeton, New Jersey, United States UroGen Full timeAbout the RoleWe are looking for a highly motivated and experienced Associate Medical Director to join our Medical Affairs team.The ideal candidate will have a terminal degree (PhD, PharmD, or another doctorate) and experience in Urologic Oncology and rare diseases. Strong oral and written communication skills are required, including presentation skills.This...
-
Senior Associate Director of Communications
3 months ago
Princeton, United States InsideHigherEd Full timeOverviewPrinceton University’s Office of the Dean for Research (ODFR) is seeking a Senior Associate Director of Communications to lead communications operations, support the evolving needs of our world-class research community, and enhance ODFR’s impact on campus. The ODFR prides itself on being a service-driven organization with a culture of constant...
-
Associate Director Statistical Programming
14 hours ago
Princeton, United States Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
R&D Quality Assurance Senior Associate II
2 months ago
Princeton, United States Aequor Technologies Full timeTitle: Sr. Quality Risk & Compliance Associate Location: Princeton, NJ Duration: 12 MonthsJob Description: This role will work closely with the other team members in Quality Risk & Compliance (QRC) to assist in assessment, reporting on compliance and improvement of processes, tools and systems for clinical trials' execution in a Good Clinical Practices...
-
Senior Associate Director, Class Enagagement
4 days ago
Princeton, United States InsideHigherEd Full timeOverviewThe Senior Associate Director, Class Engagement is responsible for informing, involving and inspiring alumni engagement across Princeton’s undergraduate alumni population and introducing current students to Princeton’s alumni traditions and opportunities for lifelong connections. Reporting to the Director of Alumni Communities, the Senior...
-
Princeton, United States InsideHigherEd Full timeOverviewThe Senior Associate Director, Regional Alumni Engagement is responsible for informing, involving and inspiring alumni engagement across Princeton’s global network of regional associations. Reporting to the Director of Alumni Communities, the Senior Associate Director will manage a team and oversee a network of approximately 1,500 alumni volunteers...
-
Associate Director
1 week ago
Princeton, New Jersey, United States Infosys Limited Digital Full timeAbout Us:At Infosys Limited Digital, we are committed to enabling clients in more than 50 countries to navigate their digital transformation.Job Summary:We are seeking an Associate Director - Client Partnerships to join our team. The successful candidate will lead all client interfaces within the assigned account scope, building strong relationships with CXO...
-
Associate Director, US Marketing
24 minutes ago
Princeton, United States Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com.Associate Director, US Marketing - HematologyLocations: Princeton, NJPosted: 3 Days AgoJob Requisition ID: R12202At Genmab, we’re committed to building extraordinary futures...
-
Associate Director, Business Development
2 hours ago
Princeton, United States Otsuka Pharmaceutical Co., Ltd Full timeAssociate Director, Business Development (Scientific Evaluation) Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet...
-
Senior Associate Director, Gift Planning
3 months ago
Princeton, United States InsideHigherEd Full timeOverviewPrinceton University Office of Advancement is seeking a dedicated Senior Associate Director, Gift Planning to join their Capital Giving team. As a frontline gift officer, the Senior Associate Director will play a key role in securing significant gifts through bequests, trusts, split-interest giving vehicles, illiquid or non-marketable assets, and...
-
Associate Director, Training Development
1 month ago
Princeton, United States InsideHigherEd Full timeOverviewWe are seeking a passionate Associate Director to oversee the training and help desk team within the Data Strategy & Innovation (DS&I) unit of the Office of Advancement. Reporting to the Director of Support Services, you will be responsible for developing and delivering engaging learning experiences across various modalities, leveraging technology to...
-
Princeton, United States Bristol-Myers Squibb Full timeAssociate Director, Procurement, Business Partner - ITApply locations Princeton LVL - NJ time type Full time posted on Posted 3 Days Ago job requisition id R1587926Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
-
Princeton, United States Genmab AS Full timeAssociate Director, US Marketing – Key Customer StrategyAssociate Director, US Marketing – Key Customer StrategyApply locations Princeton, NJ posted on Posted 2 Days Ago job requisition id R12472At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of...