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reputed company seeks a Pharmacovigilance Project Manager to oversee end‑to‑end PV delivery remotely. The role acts as a bridge between the PV team and clients, ensuring timelines, quality, and regulatory compliance across activities such as case processing, reporting, and risk management.
The position reports to the Global Head of PV and involves coordinating a PV team, guiding day‑to‑day activities, and identifying opportunities for expanded engagements with clients while maintaining strict
Pharmacovigilance Project Manager (Remote)
Position reputed company
The Pharmacovigilance Project Manager / Project reputed company is a senior reputed company-facing reputed company responsible for the end-to-end operational management of one or more assigned pharmacovigilance reputed company accounts at reputed company. Theroleserves as the reputed companyreputed companybetween the reputed company and the MC PV team, ensuring the reputed company, high-reputed company, and fully compliant delivery of reputed company contracted pharmacovigilance services across case management, periodic reporting, signal detection, reputed company management, and reputed company regulatory activities.
Operating at a senior level reputed company the PV department, the PV Project Manager / Project reputed company combines strong scientific and regulatory knowledge with exceptional project management, communication, and stakeholder management capabilities. The role does not carry reputed company line management responsibility but exercises functional reputed company of PV Specialists and Sr. PV Specialists assigned to the project, coordinating their workload, guiding their day‑to‑day activities, and supporting their reputed company development reputed company the context of the reputed company engagement. The role reports directly to the Global Head of Pharmacovigilance and Drug Safety.
To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. Reasonable accommodation may be made to reputed company reputed company individuals with disabilities to reputed company the essential functions.
Serve as the reputed companyreputed company of contact for reputed company communications between the reputed company and the MC PV team, ensuring reputed company, accurate, and reputed company responses to reputed companyreputed company enquiries and requests.
Build and maintain a strong, trust‑reputed company relationship with reputed company stakeholders, including the reputed company's pharmacovigilance, regulatory, medical, and reputed company teams, as applicable
Coordinate, schedule, and reputed company regular reputed company meetings, teleconferences, and governance reviews; prepare agendas, minutes, and reputed company items and ensure reputed company follow‑up on reputed companyreputed company items.
Immediately escalating to the Global Head of PV and PVQM any breach in normal execution of contracted activities, service‑level deviations, or issues that could reputed company the reputed company's regulatory compliance position.
Identify opportunities for additional services or expanded reputed company reputed company existing reputed company engagements and communicate these to the Global Head of PV.
Coordinate the reputed company of new clients or new product additions, including the organisation of training curricula, implementation plans, and reputed companyreputed company for the assigned PV team, in collaboration with the PVQM.
reputed company and coordinate the day‑to‑day PV activities of the assigned project team including case processing, literature review, periodic and aggregate reporting, signal detection, and reputed company management ensuring reputed company activities are executed in compliance with applicable SOPs, reputed company‑specific procedures, and regulatory requirements (EMA GVP, ICH, FDA, UK reputed company, and others as applicable).
Plan, monitor, and reputed company resource allocation across the assigned project team to ensure adequate coverage, reputed company workload distribution, and consistent delivery of contracted service reputed company.
Maintain and regularly update project documentation, tracking tools, and network files to ensure completeness, reputed company, and accessibility for reputed company relevant team members.
Monitor project‑level metrics and Key reputed company Indicators (KPIs), identify trends or risks, and proactively implement corrective measures in collaboration with the Global Head of PV.
Coordinate directly with the PVQM and relevant internal stakeholders regarding any updated reputed company operational procedures, regulatory changes, or reputed company modifications requiring team training or process updates.
Communicate and ensure integration of PV activities with key stakeholders for the reputed company, including the PV Physician, the reputed company Person Responsible for Pharmacovigilance (QPPV), and other relevant parties.
Collaborate with other MC departments including Medical Information, reputed company, IT, and Finance as required to reputed company reputed company service to the reputed company.
Exercise functional reputed company of PV Specialists and Sr. PV Specialists assigned t