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Med Communications International

Med Communications is committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.

Pharmacovigilance Project Manager

Project ManagerProject ManagerFull TimeRemoteLeadTeam 201-500

Location

Romania

Posted

16 days ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Pharmacovigilance Project Manager

Med Communications International

Role Description The Pharmacovigilance Project Manager / Project Lead is a senior client-facing professional responsible for the end-to-end operational management of one or more assigned pharmacovigilance client accounts at Med Communications. The role serves as the primary interface between the client and the MC PV team, ensuring the timely, high-quality, and fully compliant delivery of all contracted pharmacovigilance services across case management, periodic reporting, signal detection, risk management, and related regulatory activities. Operating at a senior level within the PV department, the PV Project Manager / Project Lead combines strong scientific and regulatory knowledge with exceptional project management, communication, and stakeholder management capabilities. The role does not carry direct line management responsibility but exercises functional oversight of PV Specialists and Sr. PV Specialists assigned to the project, coordinating their workload, guiding their day-to-day activities, and supporting their professional development within the context of the client engagement. The role reports directly to the Global Head of Pharmacovigilance and Drug Safety. Qualifications - Excellent working knowledge of relevant PV terminology, ICH guidelines (E2A–E2F, E2C(R2)), GCP, GVP Modules, and applicable regulatory requirements across EU, US, and UK jurisdictions. - Advanced degree in life sciences (PharmD or MD preferred), or a relevant equivalent combination of education and pharmacovigilance experience. - Minimum of five years of pharmacovigilance experience, including at least two years in a project management, project lead, or client-facing account management role at a PV vendor, CRO, or pharmaceutical company. - Demonstrated ability to manage complex, multi-product client accounts across multiple PV domains (case management, periodic reporting, signal detection, risk management). - Experience with drugs, biologics, vaccines, and/or devices is preferred. Requirements - Proficiency with safety databases (Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube Safety), Microsoft Office Suite (Word, Excel, Outlook, PowerPoint), and project management or tracking tools required. - Familiarity with literature search platforms (Embase, OvidPV, PubMed) and document management systems is an advantage. - Working knowledge of global legal, regulatory, and compliance requirements applicable to pharmacovigilance across multiple jurisdictions (EU, US, UK, ICH). - Experience supporting or managing regulatory agency interactions and audit/inspection preparation is preferred. Benefits - Competitive salary and performance-based bonuses. - Comprehensive health, dental, and vision insurance. - Retirement savings plan with company match. - Flexible work arrangements. - Professional development opportunities.

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GPM Investments logo

Construction Project Manager

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Job Closed
Smart Freight Centre logo

Project Manager

Smart Freight Centre

We are a global mission-driven organization dedicated to a more efficient and zero-emissions global logistics sector.

Project Manager16 days ago
ContractRemoteTeam 51-200H1B No Sponsor

Role Description The Project Manager will lead SFC’s activities in Indonesia, mobilizing stakeholders, building capacity, emissions accounting alignment, and zero-emission truck (ZET) transitions assessments. This role is central to SFC’s contributions to the national freight decarbonization ecosystem and ensuring successful delivery of project milestones. The Project Manager will serve as SFC’s local representative and primary liaison to government, industry, academia, and NGO partners. Key Responsibilities - Project Coordination & Delivery - Lead end-to-end execution of SFC Indonesia workstreams across GLEC and FEC. - Manage day-to-day implementation aligned with the directional workplan (ecosystem, mobilization, training, deployment). - Ensure delivery of grant-linked outputs across ecosystem, technical, and policy tracks. - In consultation with the global team, develop and maintain the detailed workplan, timelines, and milestones. - Coordinate activities across SFC teams (GLEC, Fleet Electrification Coalition, Academy). - Prepare progress updates, reports, and supporting documentation for internal and external audiences and for donor reporting. - Ensure delivery of milestones across ecosystem, technical, and policy tracks. - Stakeholder Engagement & Ecosystem Building - Identify, onboard, and formalize partnerships (WRI, ICCT, IFDA, industry bodies) through MoUs. - Build and maintain relationships with government agencies, shippers, carriers, logistics providers, research institutions, and NGOs. - Build and anchor a Freight Electrification Coalition (FEC). - Mobilize shippers and carriers into structured engagement. - Support the formation and facilitation of national working groups, roundtables, and coordination platforms across stakeholders (Industry, Policy, and research). - Identify strategic opportunities for collaboration with local partners. - Identify key actors and engagement pathways for policy advocacy across electrification and emissions accounting. - Capacity Building & Training Support - Coordinate delivery of national workshops on GLEC / ISO 14083 Framework and Freight Electrification. - Work with the SFC Academy team to localize training materials and adapt content for Indonesian audiences. - Identify and onboard freight data partners and support development of local emission intensity pathways. - Facilitate knowledge exchange between global SFC experts and local stakeholders. - Technical Delivery (Emissions Accounting & ZET Readiness) - Work with SFC’s global Methods, Standards and Assurance team to assess data availability and readiness for emissions factors calculations. - Lead development of Methods Alignment Note and emissions accounting roadmap (GLEC / ISO 14083 aligned). - Conduct Indonesia freight market assessment and use case prioritization for electrification (e.g. drayage, urban, corridor). - Assist in gathering and interpreting data for TCO analysis and early ZET pilot scoping. - Identify and onboard freight data partners; support development of local emission intensity pathways. - Translate technical outputs into clear, decision-ready insights for industry and policymakers. - Produce quarterly technical briefs / reports capturing insights, learnings, and progress. - Governance & Documentation - Track action items, risks, and dependencies across workstream. - Ensure alignment across SFC global teams and local partners. - Maintain structured documentation of methodologies, datasets, and outputs. - Communications & Outreach - Coordinate the development of communication materials, including workshop summaries, infographics, and country updates. - Support storytelling and narrative building to position SFC as a neutral convener in Indonesia. - Support organization of public and partner-facing events; manage meeting logistics. - Liaise with SFC’s communications team to ensure consistent messaging and visibility. - Package outputs into a clear “market signal” narrative (coalition, TCO, pilots, policy direction). - Partnership & Resource Development - Support the drafting of the Phase 2 multi-year proposal (2027-2029) informed by stakeholder insights and program outcomes. - Contribute to funding proposals, donor reporting, and partner engagement strategies. - Identify opportunities to expand SFC’s presence across Indonesia and Southeast Asia. - Support transition from pilot program to long-term institutional engagement. Timeline and Deliverables - Establish a strong national freight decarbonization ecosystem and demand base. - Create 4 MoUs governing the relationship and objectives with local leading NGOs (ICCT, IFDA, ICCT) by July 2026. - Mobilize at least 20 Shippers and carriers by Aug 2026. - Publicly launch an e-truck coalition of shippers in Oct / Nov 2026. - Deliver one in-person 1-day truck electrification training by Q2 2026, with support from SFC global leads. - Establish a national foundation for GLEC / ISO 14083 aligned emissions accounting. - Deliver national capacity-building workshop series (x3) for shippers, carriers, LSPs, government, industry, and academia starting Q2 2026. - Develop a 'Methods Alignment Note' documenting harmonization of existing data sets (if available) with the GLEC Framework. - Produce quarterly technical briefs capturing progress on emissions alignment, data gaps, and ecosystem readiness. - Conduct Indonesia freight market assessment and use case prioritization (e.g. drayage, urban, corridor) by Q2 2026. - Analyze 2 to 3 TCO use cases by Aug 2026. - Develop a comprehensive ZET deployment roadmap and TCO pathway to parity by Nov 2026. - Translate all technical outputs into decision-ready insights for industry and policy stakeholders. Qualifications - Minimum 7 years of experience in sustainability, climate policy, transport/logistics, or related fields. - Strong understanding of Indonesia’s policy and industry landscape, particularly in transport, energy, or environmental sectors. - Demonstrated experience coordinating multi-stakeholder projects involving government, industry, and civil society. - Excellent organizational, communication, and project-management skills. - Ability to manage complex relationships and represent an international organization with professionalism. - Fluency in Bahasa Indonesia and proficiency in English required. - Ability to travel domestically within Indonesia. Preferred Qualifications - Experience with freight/logistics, electrification, or transport decarbonization initiatives. - Familiarity with emissions accounting frameworks (e.g., GLEC), life-cycle analysis, or TCO modelling. - Existing industry network in logistics and transport in Indonesia. - Track record in running multi-topic, multi-stakeholder projects in the country. - Background working with international NGOs, donor-funded programs, or technical coalitions. Organizational Culture and Work Environment At Smart Freight Centre (SFC), our culture is rooted in collaboration, innovation, and sustainability. We value every team member's contribution and foster an inclusive environment where diverse perspectives drive industry transformation. Our commitment to sustainability extends to our work environment. We promote work-life balance, continuous learning, and professional growth, investing in our team members' well-being.

Indonesia