
PV Governance
4 weeks ago
- As a Lead for PV Governance & Compliance in our Bangalore office, you will play a crucial role in overseeing Pharmacovigilance (PV) compliance within the clinical development and medical affairs organization. Reporting directly to the Head of Pharmacovigilance, your responsibilities will include ensuring adherence to global regulatory requirements, standard operating procedures (SOPs), work instructions, training, audits, inspections, and CAPA management.Your leadership skills will be essential as you collaborate with internal and external stakeholders, overseeing PV contracts, PV Single Drug Event Agreements (SDEAs), QPPV contract coordination, and Pharmacovigilance System Master File (PSMF) management.Key Responsibilities:- Monitor, report, and manage metrics and key performance indicators (KPIs) related to global pharmacovigilance compliance.- Ensure quality and compliance activities align with policies, guidelines, regulatory requirements, and standards globally and regionally.- Uphold high-quality and compliance standards across all processes with a focus on continuous improvement.- Oversee KPIs, reporting, and associated Corrective and Preventive Actions (CAPAs).- Manage Quality Management Plans and the Pharmacovigilance Safety Master File (PSMF).- Collaborate on PV service provider-specific SOPs, Work Instructions, and global PV-related documents.- Support deviation development within the Quality Management System (QMS) and associated CAPAs.- Stay updated on PV regulations for specific countries and regions.- Develop responses to audit and inspection reports, including CAPA implementation.- Participate in quality review meetings and analyze performance trends for ongoing improvement.- Lead Change Management Oversight and ensure vendor compliance with PV services.- Fulfill pharmacovigilance commitments to regulatory authorities regarding marketing authorization.- Lead audit and inspection readiness efforts and participate in regulatory inspections and audits.- Address audit findings and compliance issues through corrective and preventive actions.- Perform any other duties as assigned.Your role will be instrumental in maintaining PV compliance standards, driving quality improvement initiatives, and ensuring alignment with global regulatory requirements. Your proactive approach and strong communication skills will be crucial in successfully managing PV governance and compliance functions.,
- Job Tags business process quality, quality assurance, capa, quality management, inspection
Sign-in & Get noticed by top recruiters and get hired fast
#J-18808-Ljbffr-
Fulfilment Operations Supervisor
4 days ago
Singapore PLAIN VANILLA BAKERY PTE. LTD. Full time**Responsibilities**: - Responsible for timely and accurate packing and dispatch of daily production runs to stores. - Responsible for troubleshooting and resolving daily production run-related issues. - Manage and oversee the packing process for all PV Foods inventory to achieve inventory quantities determined by Management in a timely fashion. -...
-
Solar Account Manager
3 days ago
Singapore T K A CONSTRUCTION PTE. LTD. Full time $80,000 - $120,000 per yearResponsibilitiesManage the structuring and negotiation of solar leasing and turnkey agreementsPrepare financial model to assess the returns of the projectPrepare, submit proposal/tender bids, follow-up and carry out tender presentationsAchieve the required sales targets of solar PV projectWork closely with Solar Project Management & O&M team and EPC...
-
Central Kitchen Operations Partner
2 weeks ago
Singapore PLAIN VANILLA BAKERY Full timeKey Job Duties and Responsibilities Daily Deliveries to Stores Manage and oversee the timely and accurate packing and dispatch of daily production runs to internal points of sale. Responsible for troubleshooting and resolving daily production run-related issues and supporting the stores in maintaining a healthy daily inventory level. Manage...
-
Underwriter, Terrorism and Political Violence
14 hours ago
Singapore Allianz Global Corporate & Specialty Full time**Underwriter, Terrorism and Political Violence - APAC** **Let’s care for tomorrow.** **Your ambitions. Your dreams. Your tomorrow** At AGCS, we are the global leader for insuring corporate and specialty risks in the Allianz Group. Whether it’s aircraft, satellites, the world’s biggest ships and tallest building, cyber-attacks or climate change...
-
F&B Operations Manager
2 weeks ago
Singapore Plain Vanilla Bakery Full time $40,000 - $80,000 per yearKey Job Duties and ResponsibilitiesDaily Deliveries to StoresManage and oversee the timely and accurate packing and dispatch of daily production runs to internal points of sale.Responsible for troubleshooting and resolving daily production run-related issues and supporting the stores in maintaining a healthy daily inventory level.Manage communications...
-
Deputy Class Underwriter
3 days ago
Singapore CHAUCER SINGAPORE PTE. LIMITED Full time $60,000 - $80,000 per yearJob Profile SummaryResponsible for providing support to the Underwriting team especially to interpret, prepare and analyse underwriting data to provide comprehensive modelling information to support the underwriting processJob DescriptionSupporting Class and other Underwriters in all aspects of the underwriting and management of the accountCoordination and...
-
Solar Account Manager
4 weeks ago
Singapore T K A CONSTRUCTION PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilities• Manage the structuring and negotiation of solar leasing and turnkey agreements• Prepare financial model to assess the returns of the project• Prepare, submit proposal/tender bids, follow-up and carry out tender presentations• Achieve the required sales targets of solar PV project• Work closely with Solar...
-
Analyst/ Senior Analyst
1 week ago
Singapore Energy Market Authority Full time**What the role is** - Singapore is transforming our energy sector to address climate change challenges. One way is to tap on electricity imported from regional power grids, to allow Singapore to access cleaner energy resources outside Singapore's borders. EMA will also be encouraging the adoption of demand‐side measures, so that consumers can help in the...
-
Project Manager
2 days ago
Singapore CLIMATE RESOURCES EXCHANGE INTERNATIONAL PTE. LTD. Full timeLeading technical proposals for clients with respect to carbon profiling, originating carbon emission reduction projects under the CDM-UNFCCC, VERRA, GS, GCC, and other international Standards. - Prepare calculations for reports of emissions streams: Scope 1 - 3 under the GHG Protocol - Conduct On-Site Visits, evaluate environmental impact assessment,...
-
Business Excellence Analyst
2 days ago
Central Singapore Sembcorp Industries Full timeSingapore, Central, Singapore - Department- Business Excellence- Job posted on- Oct 01, 2024- Employment type- Permanent**About Sembcorp Industries** Sembcorp Industries (Sembcorp) is a leading energy and urban solutions provider, led by its purpose to drive energy transition. Headquartered in Singapore, Sembcorp delivers sustainable solutions to support...