Current jobs related to Manager Ii, Pharmacovigilance - Irvine - Tarsus Pharmaceuticals
-
Medical Director, Device Safety Expert
6 days ago
Irvine, California, United States AbbVie Full timeJob SummaryThe Medical Director, Device Safety will play a critical role in ensuring the safety of our medical devices. This individual will be responsible for supporting the Product Safety Leads and potentially leading the safety efforts for one or more products. The successful candidate will have a strong background in pharmacology, chemistry, and...
-
Medical Director, Device Safety
14 hours ago
Irvine, California, United States AbbVie Full timeJob Title: Medical Director, Device SafetyAt AbbVie, we are seeking a highly skilled Medical Director to lead our device safety efforts. As a key member of our team, you will be responsible for ensuring the safety of our medical devices through surveillance, signal detection, validation, and assessment.Responsibilities:Conduct safety surveillance for...
-
Medical Director, Device Safety
3 months ago
Irvine, United States AbbVie Full timeCompany DescriptionJob Description The Medical Director is responsible for supporting the Product Safety Leads (PST) and potentially support one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA Head in ensuring safety in one or more products to through surveillance, signal detection, validation and...
-
Irvine, California, United States AbbVie Full timeJob SummaryThe Medical Director, Device Safety and Surveillance will play a critical role in ensuring the safety of our medical devices and products. This individual will be responsible for supporting the Product Safety Leads and potentially leading the safety surveillance efforts for one or more products.Key ResponsibilitiesSurveillance and Signal...
-
Managed Care Specialist II
16 hours ago
Irvine, California, United States University of California Full timeAbout the RoleWe are seeking a highly skilled Managed Care Specialist II to join our team at the University of California, Irvine. As a key member of our healthcare contracting team, you will play a critical role in managing the implementation of new and amended contracts, providing updates and clarifying contract-related information to internal departments,...
-
Volkswagen Express Technician
3 weeks ago
Irvine, California, United States Irvine Auto Retail II Inc Full timeJob DescriptionWe are seeking a skilled Express Technician to join our team at Irvine Auto Retail II Inc.Location: Irvine, CA | Type: Full Time | Compensation Range: $18/hr-$20/hrIrvine Auto Retail II Inc. is a reputable automotive dealership group with a long history of delivering exceptional service to customers. We are currently seeking a dedicated...
-
Project Manager II
2 days ago
Irvine, California, United States BSH Home Appliances Group Full timeProject Manager IIAbout the RoleThe Project Manager II is a key member of our product development team, responsible for ensuring the successful implementation of new products within the Division for BSH North America. This role requires strong leadership and project management skills, with a focus on delivering high-quality products on time and within...
-
Solar Construction Manager II
6 days ago
Irvine, California, United States EMCOR Group Full timeAbout the RoleWe are seeking a highly skilled Solar Construction Manager II to join our team at EMCOR Group. As a key member of our solar energy division, you will be responsible for overseeing the construction of solar energy systems, ensuring projects are completed on time, within budget, and to the highest quality standards.Key ResponsibilitiesParticipate...
-
Solar Construction Manager II
59 minutes ago
Irvine, California, United States EMCOR Group Full timeAbout the RoleWe are seeking a highly skilled Solar Construction Manager II to join our team at EMCOR Group, a leading provider of mechanical and electrical construction and facilities services. As a key member of our team, you will be responsible for overseeing the construction of solar energy projects from preconstruction to close-out.Key...
-
Solar Construction Manager II
3 days ago
Irvine, California, United States EMCOR Group Full timeAbout the RoleWe are seeking a highly skilled Solar Construction Manager II to join our team at EMCOR Group. As a key member of our solar energy division, you will be responsible for overseeing the construction of solar energy projects from preconstruction to close-out.Key ResponsibilitiesParticipate in preconstruction planning to ensure project schedules...
-
IAM Security Engineer II
8 hours ago
Irvine, California, United States Capital Group Full timeJob Title: IAM Security Engineer IICapital Group is seeking a highly skilled IAM Security Engineer II to join our Identity and Access Management (IAM) Engineering team. As an IAM Security Engineer II, you will play a critical role in designing, implementing, and maintaining secure identity and access management systems for our enterprise.Key...
-
Solar Construction Manager II
7 days ago
Irvine, California, United States Emcor Inc Full timeAbout the RoleMesa Energy Systems, a subsidiary of EMCOR Group, Inc., is seeking a highly skilled Solar Construction Manager II to join our team. As a leading provider of mechanical and electrical construction and facilities services, we offer a comprehensive benefits package and a competitive salary.Key ResponsibilitiesParticipate in preconstruction...
-
Project Manager II
3 weeks ago
Irvine, United States BSH Home Appliances Group Full timeBSH Home Appliances Corporation – Top Employer US 2024 Tomorrow is our home. At BSH, People Matter. Bring your unique skills, capabilities, and experiences to our dynamic teams where your contributions will drive our innovation culture. We strive to be a workplace that values people and supports opportunities for continuous professional and...
-
Financial Specialist II
1 day ago
Irvine, California, United States Western Growers Family of Companies Full timeJob Title: Financial Specialist IIWestern Growers Family of Companies is seeking a highly skilled Financial Specialist II to join our team. As a key member of our finance department, you will be responsible for processing financial transactions, maintaining accounts receivable, and managing vendor payments.Key Responsibilities:Maintain and balance group and...
-
Solar Construction Manager II
6 days ago
Irvine, California, United States Emcor Inc Full timeAbout the RoleMesa Energy Systems, a subsidiary of EMCOR Group, Inc., is seeking a highly skilled Solar Construction Manager II to join our team. As a leading provider of mechanical and electrical construction and facilities services, we offer fully integrated solutions for preventative maintenance and repair, upgrading existing mechanical, electrical, and...
-
Project Manager II
1 week ago
Irvine, California, United States BSH Home Appliances Group Full timeAbout the RoleWe are seeking a highly skilled Project Manager II to lead our product development projects in the North America region. As a key member of our team, you will be responsible for ensuring the successful launch of new products, managing project timelines, and collaborating with cross-functional teams to drive business growth.Key...
-
Physical Therapist II
8 hours ago
Irvine, California, United States Hoag Memorial Hospital Presbyterian Full timeJob SummaryWe are seeking a highly skilled Physical Therapist II to join our team at Hoag Memorial Hospital Presbyterian. As a Physical Therapist II, you will be responsible for assessing patients' physical therapy needs and developing personalized treatment plans.Key ResponsibilitiesConduct thorough assessments of patients' physical therapy needs, including...
-
Licensed Vocational Nurse II
3 weeks ago
Irvine, California, United States City of Hope Full timeLicensed Vocational Nurse II At City of Hope, we are dedicated to transforming lives and making a significant impact in the battle against cancer, diabetes, and other serious health conditions. Our expanding national network includes various clinical care locations across Southern California, along with treatment facilities in major cities. Our compassionate...
-
Account Associate II
4 days ago
Irvine, California, United States Alliant Insurance Services Full timeJob SummaryWe are seeking a highly skilled and detail-oriented Account Associate II to join our team at Alliant Insurance Services. As an Account Associate II, you will be responsible for providing exceptional client service and support in a fast-paced environment.Key ResponsibilitiesInvestigate and resolve client and employee issues related to enrollment...
-
Call Center Analyst II
6 days ago
Irvine, California, United States Lukos Full timeJob Title: Call Center Call Analyst IILukos is seeking a highly skilled Call Center Call Analyst II to join our team. As a Call Center Call Analyst II, you will be responsible for conducting call intake for all ECCO phone lines and operator call analyses functions as directed by the SOP and call center leadership.Key Responsibilities:Must perform at the...
Manager Ii, Pharmacovigilance
4 months ago
**About the Role**
The Manager II, Pharmacovigilance (PV) reports to our Sr Dir, Head of Pharmacovigilance. This individual will work with the PV team and cross-functional members to implement and maintain Drug Safety and PV regulations into Quality Management Systems and help build and maintain a robust PV compliance system. This role will also assist with call center scripts development, maintenance, and liaise on reconciliation activities.
**Let's talk about some of the key responsibilities of the role**:
- Ensure PV processes are implemented meeting quality and compliance requirements for case management and regulatory submission activities.
- Implement and maintain Drug Safety and Pharmacovigilance (PV) legislation into Quality Management Systems and contribute to development of standard operating procedures (SOPs) and work instructions (WIs) for quality assurance in DSPV system.
- Implement corrective and preventive actions (CAPAs), note to files (NTFs) and other deviation documentation to address any identified deficiencies.
- Ensure and assist audits (internal and external) and inspection readiness, preparation developing audit plans, and maintaining compliance with applicable SOPs, regulations, and guidelines with the Regulatory agencies.
- Assist in preparation of Aggregate Safety Reports (e.g DSURs, PADERs, PBRERS), review and conduct quality checks (QC) of these documents as needed.
- Sample and conduct routine quality checks on individual case safety reports (ICSRs) in both clinical and post-marketing settings to ensure compliance with DSPV requirements.
- Contributes to ongoing safety surveillance efforts for marketed and investigational products via support on surveillance document review, QC, and assist preparation.
- Act as main strategic liaison between Tarsus call center and internal team members by managing and coordinating communications between different teams to ensure concerns are addressed and necessary changes implemented to improve the call center. Oversees external vendor(s) to ensure any projects or changes are properly implemented in a timely manner. Assists with devising and drafting operational processes that streamline workflows for seamless implementation.
- Support call center script development, review and update scripts with internal team members and external vendor(s) to ensure alignment with implementation timelines.
- Support and contribute to Call Center reconciliations and oversight of safety related reports or inquiries.
- Assist in regulatory agency (RA) or health authority (HA) queries response requests as required. Assist with implementing any follow-up actions from RA/HA findings.
- Trains outside vendor(s) to ensure they are up to date with Tarsus regulations and requirements.
- Maintain up to date knowledge of pharmacovigilance and drug safety related regulations, the regulatory environment, and company SOPs.
- Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and regulatory compliance of the pharmacovigilance and drug safety system and quality assurance activities.
**Factors to Success**
- Bachelor's degree in science or healthcare field or equivalent
- 5-7 years of biotech or pharmaceutical industry experience; including a minimum of 3-5 years in pharmacovigilance and/or pharmaceutical business processes operations
- Working experience and strong understanding of global pharmacovigilance regulations, FDA/GVP/ICH guidance, and industry best practices including Good Clinical Practices (GCP)
- Working experience on regulatory agencies inspections and/or internal or third-party audits
- Proficient in ICSR and SUSARs case processing processes, procedures, conventions
- Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external vendors.
- Detail-oriented with strong analytical thinking and problem-solving capabilities.
- Basic experience using excel file for data review and analysis.
**A Few Other Details Worth Mentioning**:
- The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment.
- Remote work is also an option for this position.
- This position reports directly to the Sr Dir, Head of Pharmacovigilance.
LI-Remote
LI-Hybrid
