Senior Pharmacovigilance Executive
Proclinical is currently recruiting for a Senior Pharmacovigilance Executive for a specialist consultant company located in Hertfordshire, England. Successful candidate will act with a significant degree of independence to fulfil assigned project responsibilities and activities, work closely with and provide support to the PV Manager and build positive working relationships with clients and colleagues.
- Represent the PV department within the company.
- Establish and maintain appropriate interfaces with other company departments (e.g. Regulatory Affairs, Quality Assurance).
- Conduct intra and inter-departmental company PV training.
- Write, review and approve company PV standard procedures and associated quality system documents.
- Manage and maintain the company safety database.
- Maintain the Company PV system as audit and inspection ready.
- Maintain the Company's philosophy and ethos.
- Maintain self-development under the guidance of the Line Manager.
- Undertake self-directed education by reading and assimilating subject relevant national and regional PV legislation.
- Participate in training sessions and workshops, including presenting reports from any conferences attended.
- Ensure that all internal systems are routinely updated as appropriate (e.g., Synergist Timesheets, Training records etc.)
- Periodic Safety Update Reports (PSURs)/Development Safety Update Reports (DSURs)/PADERs within agreed regulatory timelines.
- Pharmacovigilance System Master Files (PSMFs)
- Annual Safety Reports (ASRs).
- Maintain eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD).
- Perform case processing for Marketed Product ADRs and Clinical Trial SAEs to include coordination of medical review as required.
- Perform timely submission of Individual Case Safety Reports (ICSRs) to relevant Competent Authorities (CAs) and ECs.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry at (+44) 207 4400 636 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A great career opportunity has emerged at a multinational pharmaceutical company that specialises in developing life-transforming therapies for patients with severe and life-threatening diseases.