Snr Pharmacovigilance Specialist - Contract
Hendre Moolman at CK Clinical is recruiting for a Senior Pharmacovigilance Specialist to join a global pharmaceutical company at their site based in Hertfordshire on a contract basis.
Your main responsibilities in this role will be to:
- Report to the Pharmacovigilance Country lead and be responsible for case management activities for post marketing and Investigational products in the UK/Ireland.
- Work directly with Global Safety colleagues, Data Management Centres and other cross functional departments.
- Process spontaneous and solicited / clinical trial adverse event reports from the UK/Ireland and liaising with Data Management Centre, contractual partners regarding reports.
- Perform QC of cases.
- Liaise with healthcare professionals and ensure accuracy of adverse experience queries, and follow up requests.
- Conduct reconciliation of adverse event reports received from other operating units or contractual partners as applicable.
- Liaise with Global Safety and Regulatory colleagues regarding PV issues.
- Identify and communicate potential safety issues.
- Manage aggregate report submissions.
- Serve as point of contact for the local health Authority and liaise with colleagues for questions from local HA regarding safety and ICSRs.
- Liaise with colleagues in Global Clinical Trial Operations, Global regulatory Affairs (GRA) and Global medical Affairs (GMA) and other business units to ensure processes are in place for activities performed by those functions that impact PV.
- Ensure compliance with PV regulations and Global Safety policies, proposing corrective actions.
- Support of audits and inspection activities for the country/territory including readiness activities, participation and CAPA activities.
- Deliver training to PV staff and customer facing non-PV staff and distributors.
- Train and mentor PV Staff
- Serve as back-up coverage in the absence of the Pharmacovigilance Country lead to ensure business continuity.
You are required to have the following qualifications, skills and experience:
- Health, life science or medical science degree (or equivalent qualifications/experience).
- Knowledge of Pharmacovigilance systems and requirements within the pharmaceutical industry.
- Extensive knowledge of Pharmacovigilance regulations in Europe and the UK/Ireland.
- Excellent communication skills.
- Be well organised, efficient and self-motivated with the ability to work under pressure to meet strict deadlines.
- Meticulous attention to detail.
- Strong team player.
- Sense of urgency and the ability to make rapid, disciplined decisions.
- Good problem solving capacity.
- Good training skills.
- Good leadership and interpersonal skills.
If you are employed by this client you will be joining a global pharmaceutical company based in Hertfordshire. Other benefits include:
- Competitive hourly rate
For more information or to apply for this Senior Pharmacovigilance Specialist position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org. 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 campaign. Entitlement to work in the EEA is essential. Please quote reference CL33731 in all correspondence.