- Ensure audit preparedness and manage regulatory and internal inspections
- Draft any corrective action/preventative action plans(CAPA) as necessary
- 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)
- Ensure MIs are addressed in a timely manner as per internal procedures and address and support responses to MIs as needed
- 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
- Develop Drug Safety Standard Operating Procedures and ensure training for Drug Safety personnel
- ADE management per applicable procedures
- Ensure ADEs are forwarded to GPV for processing and ensure follow ups for ADEs are performed as applicable
- 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
- PharmD, Master's in Pharmaceutical Sciences or MD required
- 10-12 years' experience in Pharmacovigilance or related field
- Supervisory experience required
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Drug Safety Physician
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GForce Life Sciences Princeton, NJ, United StatesThe Project Physician tasks may include: · Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documents · Contribute to writing and r ...
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Drug Safety Physician
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GForce Life Sciences Princeton, United StatesThe Project Physician tasks may include: · Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documents · Contribute to writing and r ...
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Clinical Resource Network (CRN) Princeton, United StatesOur client is looking to fill the role of Drug Safety Physician. This role will be hybrid and based out of the Princeton office. · Responsibilities: · Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, s ...
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Drug Safety Physician
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GForce Life Sciences Princeton, United StatesThe Project Physician tasks may include:Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documents · Contribute to writing and revi ...
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drug safety associate
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Sun Pharmaceutical Industries Princeton, NJ, United StatesCOME 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 Pr ...
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Associate Director, Drug Safety
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Sun Pharmaceutical Industries Princeton, United StatesIND123 · 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 st ...
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Director, Global Drug Safety
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GENMAB A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Director, Global Drug Safety
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Genmab Princeton, United StatesJob Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...
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Director, Drug Safety
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Tris Pharma Monmouth Junction, United StatesApply · Description · Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more than 150 US and International patents (including app ...
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Associate Director, Global Drug Safety
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GENMAB A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Director, Drug Safety
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Tris Pharma Monmouth Junction, United States Full timeTris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more than 150 US and International patents (including applications) and have ma ...
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Associate Director, Global Drug Safety
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Genmab Princeton, United StatesJob Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...
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Associate Director, Global Drug Safety
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Genmab Princeton, United StatesJob Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...
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ACADIA Pharmaceuticals Inc. Princeton, United StatesPlease 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 scie ...
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Associate Director, Global Drug Safety
1 week ago
GENMAB A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Director Risk Management, Drug Safety
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ACADIA Pharmaceuticals Inc. Princeton, United StatesPlease 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 ...
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Associate Director, Global Drug Safety
1 week ago
Genmab Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Genmab Princeton, NJ, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Vice President-Drug Safety
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ADC Therapeutics New Providence, NJ, United StatesWFH Flexible · • New Providence, NJJob TypeFull-timeDescriptionDescriptionTransforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.Why ADC ...
Associate Director, Drug Safety - Princeton, United States - Sun Pharmaceutical Industries
Description
IND123The 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 followingFDA, Health Canada and Internal Audit Inspections:
Compliance Monitoring:
Medical Inquiry (MI) Management:
Exchange of Safety Information with Business Partners:
Risk Management
Archival
People Engagement
Qualifications: