Pharmacovigilance Project Manager
Hendre Moolman at CK Clinical is recruiting for a Drug Safety Project Manager to join a global company in the pharmaceutical sector at their site based in Hertfordshire on a permanent basis.
Your main responsibilities in this role will be to:
- Perform the role of the Project Manager for pharmacovigilance projects as assigned by the VP, Operations and Pharmacovigilance
- Provide advice on pharmacovigilance strategy and requirements for investigational and marketed products to pharmaceutical and biotechnology clients.
- Lead/participate in specific projects as directed by the VP, Operations and Pharmacovigilance.
- Participate in client meetings and liaise with clients regarding ongoing projects.
- Assist with establishing clients' pharmacovigilance systems including preparation and/or review of SOPs, safety management plans and pharmacovigilance data management plan.
- Assist with maintenance of pharmacovigilance systems including preparation and/or review of SOPs, working instructions and other working tools such as forms and spread sheets and safety databases.
- Preparation, coordination and review of key pharmacovigilance related regulatory documents for both investigational and marketed products, including the DSUR, PSUR, EU-RMP, PSMF, SDEA.
- Co-ordination and execution of on-going activities such as literature review, signal detection, project steering committee meetings, liaison with QPPV and local QPPVs, management of labelling documents, interaction with regulatory authorities.
Oversight of project activities and provide input into invoicing for specified projects Ensure compliance with regulatory requirements including contribution to client and/or quality systems
Liaise with VP Operations and Pharmacovigilance and Pharmacovigilance Department re personal workloads, programme status & resource requirements.
- When required, manage and support, pharmacovigilance case management activities including SAE case entry, regulatory assessment of SAEs and submission to relevant Authorities
- Provide input into clinical, scientific, regulatory and other services provided.
- Maintain awareness of regulations and changes to regulations concerning pharmacovigilance.
- Inform VP, Operations and Pharmacovigilance and QA function of significant changes.
- Prepare and maintain project specific procedural documents such as SAE management plan and PV data management plan (includes maintaining any appendices or associated documents)
- Ensure case management team, other project team members and any other concerned party receives training at the start of the project and training updates when required
- Ensure project documentation and filing is maintained (current versions identified)
- Proactive liaison with client, project team and any other concerned party
- Respond to client, project team and any other concerned party requests
- Preparation of aggregate reports
- Literature review (routine weekly and ad-hoc for aggregate data analysis)
- Signal detection
- Client meetings - organise, produce minutes and chair (if appropriate)
- Co-ordinate EEA QPPV and LQPPV activities
- Any other PV activities such as SDEA, PSMF, RMP, issue resolution
- Assist accounts management in the preparation of fee invoices
- Approve hours undertaken by contracted project team members (unless they are case management only)
- Approve project expenses to be recharged
- Project-level CAPA management
You are required to have the following qualifications, skills and experience:
- Proven Drug Safety/Pharmacovigilance background
- Degree qualified
- Project Management experience
- Experience working on DSUR, PSUR, EU-RMP, PSMF, SDEA, and CAPAs
If you are employed by this client you will be joining a global pharmaceutical company based in Hertfordshire.
For more information or to apply for this Drug Safety Project Manager position please contact Hendre Moolman on +44 (0)1438 842 970 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process. Entitlement to work in the EEA is essential. Please quote reference CL31378 in all correspondence.