Associate Director, Drug Safety
3 weeks ago
IND123
The Associate Director/ Director, Drug Safety (Title is comensurate with experience) will oversee and implement operations of Pharmacovigilance in North America and communicate relevant information internally and with other members of SUN and its affiliates, including stakeholders as required. The Director will be responsible for ensuring ADE training and/or communication of handling ADEs for non-Drug Safety personnel and review market research surveys received from a pharmacovigilance perspective.
Responsibilities include the following
FDA, Health Canada and Internal Audit Inspections:
* Ensure audit preparedness and manage regulatory and internal inspections
* Draft any corrective action/preventative action plans(CAPA) as necessary
Compliance Monitoring:
* Ensure compliance to PV SOPs implemented in North America and generate the regional monthly PV report
* Provide root cause analysis (RCA) and CAPA for North America late reporting as applicable
* Ensure procedural deviations are appropriately documented.
* Oversee subset of quality review/quality management of Individual Case Safety Reports (CSRs)
Medical Inquiry (MI) Management:
* Ensure MIs are addressed in a timely manner as per internal procedures and address and support responses to MIs as needed
Exchange of Safety Information with Business Partners:
* Manage drafting, execution and maintenance of Safety Data Exchange Agreements (SDEAs)
* Negotiate SDEAs with BPs
* Review QA agreements and business contracts and review of PV obligations as per the SDEAs
SOPs training
* Develop Drug Safety Standard Operating Procedures and ensure training for Drug Safety personnel
Adverse Drug Experiences (ADEs) in North America
* ADE management per applicable procedures
* Ensure ADEs are forwarded to GPV for processing and ensure follow ups for ADEs are performed as applicable
Periodic reports
* Ensure review of periodic reports at US Drug Safety prior to submission to the FDA and approve periodic reports prior to submission
* Ensure review of Canada PSURs occurs by the Canada Drug Safety RPP or designee prior to PSUR finalization
Regulatory Report Submissions
Risk Management
Archival
People Engagement
Qualifications:
* PharmD, Master's in Pharmaceutical Sciences or MD required
* 10-12 years' experience in Pharmacovigilance or related field
* Supervisory experience required
-
Drug Safety Associate
10 hours ago
Princeton, United States APCER Life Sciences Full timeJob DescriptionJob Description Drug Safety Associate· Supervise or perform the periodic reconciliation of safety report information between the drug safety database and local PV representatives (PQC, CRO, Data Management, LSM, etc.)· Management and oversight of PV vendor(s) regarding intake and reconciliation...
-
Princeton, United States Bristol-Myers Squibb Full time**Working with Us** Challenging. 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...
-
Drug Safety Associate
2 weeks ago
Princeton, United States APCER Life Sciences Full timeJob DescriptionJob Description• Book in and Triaging of ICSRs• Perform data Entry of ICSRs in Pharmacovigilance database.• Entering source data in the database, Coding, Narrative(s) writing, and Generate Follow-up letters.• Generation of regulatory/partner submission reports and submission of cases.• Send follow-up/administrative queries.• Review...
-
Princeton, New Jersey, United States Proclinical Staffing Full timeSenior Director to VP of Immunology Drug Discovery - Permanent - OnsiteProclinical is seeking a Senior Director to VP of Biology & Immunology to join a biotech leveraging a high powered computation platform to discover and develop small molecule therapeutics against high value immunological targets. This is a permanent role located in Princeton,...
-
Director of CMC
1 month ago
Princeton, New Jersey, United States Proclinical Staffing Full timeDirector of CMC - Permanent - Princeton, NJProclinical is seeking a talented and motivated Director of CMC for a leading biotechnology company located in Princeton, NJ.Primary ResponsibilitiesThe successful candidate will play a crucial role in developing our overall API strategy, overseeing development activities, and managing CDMO partners. This role is...
-
Senior Clinical Drug Supply Associate
4 weeks ago
Princeton, United States Genmab Full timeThe Role & DepartmentGenmab is searching for an enthusiastic Senior Clinical Drug Supply Associate to be part of Global Clinical Drug Supply Operations in Copenhagen or Princeton within commute distance from our office locations to work according to your hybrid work arrangement.Having an impressive pipeline and many ongoing clinical trials, you will have a...
-
PRINCETON, NJ, 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...
-
Princeton, United States Princeton University Full timeJob Duties and Responsibilities. The Associate Director provides overall coordination of services for students registered with focusing primarily on cognitive, medical, and psychological disabilities. The Associate Director works in collaboration wit Director, Disability Services, Associate, Office, Diversity, Business Services, Skills
-
Associate Director Customer Engagement
6 days ago
Princeton, United States Ascendis Pharma Full timeWe’ve detected your location and are showing jobs in United States. Clear the filters to display jobs in all locations. Posted 1 day ago Clinical Trial Manager - Consultant - JOB ID: ELE24 Hybrid Palo Alto, California, United States ELE24 Posted 6 days ago Head of Regulatory Affairs, Oncology - Job ID: 1404 Hybrid Palo Alto, California, United States...
-
Associate Project Director
12 hours ago
Princeton, United States Novo Nordisk AS Full timeThe Associate Data Lead Project Director will lead and drive major and high complexity clinical data science projects with cross organizational assignments and deliverables important to Novo Nordisk. This includes: Define and execute the data strateg Director, Associate, Data Science, Project Management, Project Lead, Internal, Manufacturing, Business...
-
Associate Director Customer Engagement
5 days ago
Princeton, United States Ascendis Pharma Full timeHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, were advancing programs in Endocrinology Rare Disease, and Oncology. Guided by our core values of patients, science, and passion,...
-
Princeton, United States Princeton University Full timeThe AD's portfolio reflects the University's and OEVP departments' strategic priorities and programs, providing diverse experiences and campus exposure. Principle responsibilities may include: Guide multi-organization committees and working groups, e Director, Administrative, Associate, Planning, Project Management, Education
-
Safety Manager
11 hours ago
Princeton, United States Calumet Specialty Products Full timeWho are we? At Calumet we deliver innovative specialty products trusted by companies across the globe. We are the foundation to everyday essential products that help millions of people live and thrive. We are headquartered in Indianapolis and have numerous production locations in the US. We are customer focused and utilize our values of collaboration and...
-
Safety Manager
2 days ago
Princeton, United States Calumet Specialty Products Full timeSafety Manager Princeton, LA 71067, USA Req #1556 Friday, April 5, 2024 Who are we? At Calumet we deliver innovative specialty products trusted by companies across the globe. We are the foundation to everyday essential products that help millions of people live and thrive. We are headquartered in Indianapolis and have numerous...
-
Safety Manager
3 weeks ago
Princeton, United States Calumet Specialty Products Full timeSafety Manager Princeton, LA 71067, USA Req #1556 Friday, April 5, 2024 Who are we? At Calumet we deliver innovative specialty products trusted by companies across the globe. We are the foundation to everyday essential products that help millions of people live and thrive. We are headquartered in Indianapolis and have numerous production locations in the US....
-
Princeton, United States Educational Testing Service Full timeWorks with Functional Centers of Excellence to manage day-to-day operations of an existing product. Directly accountable for management of the operations for assigned product of lower size, and/or complexity working directly with Product Owner and Se Operations, Director, Associate, Product Owner, Management, Operation, Technology
-
Associate Director, Clinical Operations
3 weeks ago
Princeton, United States Sun Pharmaceutical Industries Full timeAssociate Director, Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a hybrid role and based in...
-
Princeton, United States Bristol Myers Squibb Full timeWorking with Us Challenging. 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...
-
Princeton, United States Princeton University Full timeThe AD coordinates the gender and sexuality training program within the GSRC, including leading the Peer Education Program (i.e., recruitment, training, ensuring the facilitation of educational panels in the residential colleges, outreach programs, a Director, Sexuality, Associate, Program Coordinator, Training, Education, Business Services
-
Associate Director, Clinical Operations
2 days ago
Princeton, United States Sun Pharmaceutical Industries Full timeAssociate Director, Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a hybrid role and based in...