![APCER Life Sciences](https://media.trabajo.org/img/noimg.jpg)
Drug Safety Associate
2 weeks ago
• 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 of literature articles and assessment for identifying valid ICSRs.
• Compliance to project guidelines.
• Execution of Company Standard Operating Procedures.
• Builds and maintains good relationships across functional units and company affiliates.
• Maintain awareness of changes to/new regulations affecting PVG activities.
•To carry out necessary administrative duties required for the job
• Support in the preparation of aggregate reports (if applicable)
• Support in Signal detection of the ADRs with cases received from client's products (if applicable) • Submission of product information in Eudravigilance database using eXtended Eudravigilance medical product dictionary (XEVMPD) (as applicable).
• Support management in all aspects of project management for clients
• Other duties as assigned by management.
Company DescriptionAPCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.Company DescriptionAPCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.-
Drug Safety Associate
4 weeks 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...
-
Drug Safety Associate
2 weeks 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...
-
Associate Director, Drug Safety
2 months ago
Princeton, United States Sun Pharmaceutical Industries Full timeIND123 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...
-
Associate Director, Drug Safety
2 weeks ago
Princeton, United States Sun Pharmaceutical Industries Full timeIND123 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...
-
Drug Safety Associate
2 weeks ago
Princeton, United States Sun Pharmaceutical Industries Full timeCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! * Hybrid work arrangement * Medical, Dental, Vision Benefits * Health Savings Account (HSA), Flexible Spending Account (FSA) * Prescription Drug Coverage * Telehealth and Behavior Health Services * Income Protection - Short Term and Long Term Disability Benefits * Retirement Benefits - 401k...
-
Drug Safety Associate
4 weeks ago
Princeton, United States Sun Pharmaceutical Industries Full timeCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! * Hybrid work arrangement * Medical, Dental, Vision Benefits * Health Savings Account (HSA), Flexible Spending Account (FSA) * Prescription Drug Coverage * Telehealth and Behavior Health Services * Income Protection - Short Term and Long Term Disability Benefits * Retirement Benefits - 401k...
-
Drug Safety Associate
2 months 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, United States Pharma People Full timeOur client is a leading High Growth Biotech looking to expand their PV team bringing on an Associate Director/Director, Drug Safety and Pharmacovigilance Physician to serves as a critical medical and data analytical expert for the assigned investigational. The overall goal for this company is becoming the market leaders in the ADC’ s Oncology space.What...
-
Drug Safety Systems Analyst
3 days ago
Princeton, United States Planet Pharma Full timeRESPONSIBILITIES:Supports the technical maintenance of the Pharmacovigilance (PV) database. Perform Pharmacovigilance database data retrieval activities. Executes weekly, monthly and ad hoc reports from the PV database.Perform all required Quality Control (QC) and complete documentation.Verification of Ethics Committee and Health Authority Periodic...
-
Drug Safety Systems Analyst
4 days ago
Princeton, United States Planet Pharma Full timeRESPONSIBILITIES:Supports the technical maintenance of the Pharmacovigilance (PV) database. Perform Pharmacovigilance database data retrieval activities. Executes weekly, monthly and ad hoc reports from the PV database.Perform all required Quality Control (QC) and complete documentation.Verification of Ethics Committee and Health Authority Periodic...
-
Princeton, United States ACADIA Pharmaceuticals Inc. Full timePlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Responsible for supporting the overall strategy and approaches within Medical Safety and supporting the PV management on scientific topics, and interacting with Acadia executives/leaders with respect to...
-
Princeton, United States ACADIA Pharmaceuticals Inc. Full timePlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Responsible for supporting the overall strategy and approaches within Medical Safety and supporting the PV management on scientific topics, and interacting with Acadia executives/leaders with respect to...
-
Director Risk Management, Drug Safety
4 weeks ago
Princeton, United States ACADIA Pharmaceuticals Inc. Full timePlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. The Director, Risk Management (RM) is responsible for overseeing the Acadia Risk Management System including the process for signal detection and safety issue assessment and for leading any related risk...
-
Director Risk Management, Drug Safety
2 weeks ago
Princeton, United States ACADIA Pharmaceuticals Inc. Full timePlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. The Director, Risk Management (RM) is responsible for overseeing the Acadia Risk Management System including the process for signal detection and safety issue assessment and for leading any related risk...
-
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...
-
Regulatory Affairs Associate
4 weeks ago
Princeton, United States Guerbet Full timeGuerbet is a human-scale company that aims to become a new global leader in medical imaging. Pioneer in contrast media with 90 years' experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors. The company offers a comprehensive range of...
-
Warehouse Associate
1 week ago
Princeton, United States Ollies Bargain Outlet, Inc. Full time**Join our team and live the Ollie-tude!: (Ollie’s Core Values)** - **BE A TEAM PLAYER-** Associates are expected to be supportive and work together. - **BE CARING-** How do I treat others with courtesy, dignity, and respect? - **BE VALUE OBSESSED-** Live the “good stuff cheap” mindset. - **BE COMMITTED-** Operate with grit, passion, tenacity, and...
-
Regulatory Affairs Associate
2 weeks ago
Princeton, United States GUERBET Full timeApply now " Date: Apr 30, 2024 Location: Princeton, NJ (USA), US Job Type: Graduate At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and...
-
Regulatory Affairs Associate
4 weeks ago
Princeton, United States Guerbet Full timeApply now " Date: Apr 30, 2024 Location: Princeton, NJ (USA), US Job Type: Graduate At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional...
-
Regulatory Affairs Associate
4 weeks ago
Princeton, United States GUERBET Full timeApply now " Date: Apr 30, 2024 Location: Princeton, NJ (USA), US Job Type: Graduate At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and...