Scientific Affairs Officer
- As a part of the Scientific Affairs team, you will provide a timely, high quality Medical Information service to Healthcare Professionals and members of public, including capturing adverse events and technical complaints;
- Reporting to the QPPV, you will act as one of the main contacts for the Pharmacovigilance Contract Organisation. You will be responsible for overseeing the monthly Pharmacovigilance activities including creation and quality control of ICSRs, PSURs and other applicable regulatory dossiers.
- You will act in compliance with Good Pharmacovigilance Practices (GVP) for the EU and other laws or regulations that may also be applicable;
- you will prepare marketing campaigns and maintain overview of a portfolio of products;
- you will ensure that the Quality Manual and Technical File for the company’s Medical Device is kept up to date and in accordance with current legislation.
- Respond to Medical information enquiries on company products and therapy areas including capturing adverse event and technical complaints without delay within agreed timescales and in accordance with the company SOP.
- preparation and review Standard Responses of frequently asked questions;
- monthly quality control of queries received;
- receive follow-ups/tracking/monitoring spontaneous ADRs, AE either serious or non-serious;
- communicate with the QPPV, deputy QPPV and Medical Advisor on various aspects of PV
- contribute to ongoing enhancement of PV processes and writing SOPs;
- assist with reconciliatory functions required between PV and other departments;
- provision of PV data and other relevant statistics for the compiling of compliance reports;
- ensure personnel have a training folder and set-up training folders for new staff; perform yearly training for non-PV staff
- creating and overseeing every 6 months out of hours telephone system form;
- oversight of the filing and archiving PV documentation and handling requests to remove or replace data in the system;
- receive documentation for new product acquisition and dates from GM and RTAM, informing departments about changes, filing documents received, obtain CCSI, SmPC, label and patient leaflet from former MAH, if applicable;
- perform oversight of PV activities monthly, including Quality Control of adverse events reported;
- implement corrective and preventative measures as and when necessary;
- inform QPPV and Deputy QPPV of any issues or measures that have been taken;
- coordinate action following initiation/communication of timelines/implementation and inform PV department of submission of Safety Variation;
- act as one of the main contacts between the company and marketing agencies; and
- collating information/writing/production/creation/checking of promotional material/marketing communications in compliance with Marketing and Advertising Law;
- quality control of product labelling, quality control and maintenance of essential documentation to ensure they are compliant to with the current standards and regulations;
- creation of new SOP and quality control and maintenance of existing SOP;
- processing/reporting any cases of injury/incidents and/or complaints involving the medical device in line with company’s SOP; and
- participate in the yearly audit, this also includes pre-audit and post audit requirements.
The successful candidate must have the following skills, qualifications and experience.
- a bachelor’s degree in Pharmacy;
- At least 3 years’ experience within Pharmacovigilance;
- an understanding of scientific and medical terminology;
- excellent verbal and written communication skills and must be fluent in English;
- basic computer skills in MS office applications;
- experience of producing high quality work and be detail orientated; and
- a proven ability to prioritise your work to meet required deadline.
Please reply with your CV to firstname.lastname@example.org quoting Ref IL-20200123-001