Pharmacovigilance Project Manager



Cary, NC
Full Time
2y ago

Company Description

PrimeVigilance, an Ergomed brand , was established  to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with  its HQ in Guildford, UK.  The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Job Description

PrimeVigilance is continuing to expand and is looking for an experienced Pharmacovigilance (PV) Project Manager to join our dynamic, rapidly expanding organisation.

Based in any of our Cary, North Carolina office,  the PV Project Manager will be responsible for leading and managing long term engagements with our clients.

Experienced home based project managers will also be considered.

Key Responsibilities

•  Representing the client's interest with the aim of achieving client´s goals and objectives and the Prime Vigilance’s interest with the aim of keeping the agreed project scope.

•  Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance.

•  Management of client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations.

•  Acting as the primary contact point for project-related matters for both the client and PrimeVigilance staff.

•  Project activities planning.

•  Coordinating the colleagues working on a project.

•  Maintenance of project-specific RAM (Responsibility Assignment Matrix).

•  Assurance, that all PV Division staff is familiar with the client and the project scope.

•  Assurance of training of all team members from relevant quality documents, including project-specific documentation.

•  Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones.

•  Making sure that all the outputs are delivered in high quality and before the final deadline set up by client.

•  Reporting the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.

•  Preparation of Accounting of Services and invoice, if delegated.

•  Keeping of an oversight on all communication with client.

•  Making sure that quality standards applicable to the respective client are met.

•  Having an overview of all SOPs relevant to the respective client.

•  Monitoring of compliance results and proposing corrective and preventive actions, where necessary. Preparation of Deviation reports.

•  Acting as audit/inspection coordinator, if applicable.

•  Proposing processes improvements.

•  Leading by example.

•  Proper hand-over of all open issues, ongoing project tasks and upcoming milestones and deadlines before his/her absence to project manager deputy.



  • Proven track record of 5+ years in Pharmacovigilance activities including; processing and quality review of ICSRs, writing or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs.
  • Health Care Professional or Life Science Graduate
  • Be comfortable with communicating at senior levels within pharmaceutical organisations
  • Have good leadership qualities including skills in planning, mentoring, meeting facilitation, communication and problem solving.
  • Knowledge of Argus, ARISg, Microsoft Excel, Visio and Project preferred
  • Previous experience within a service provider environment preferred


Additional Information

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company
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Onkar By: Onkar