A Hampshire (UK) based Copywriter, Medical Writer, and Regulatory Affairs/Pharmacovigilance Professional, with a Bachelor’s Degree in Veterinary Medicine and Surgery, and previous experience in academic research and clinical practice. Worked as part of transition team after takeover of Fort Dodge Animal Health by Pfizer, followed by one year working in a Medical Communications and Education Consultancy. Now seeking freelance and contract Copywriting Regulatory Affairs and Pharmacovigilance work, as well as looking to diversify into other areas of writing, including the Medical Devices, Technical Writing and Motor Industry fields.
Well practised at writing Safety Reports, Risk Assessments and other highly detailed documents for applications to National Authorities as well as producing less specialised summary documents for medical and veterinary professionals, and lay users of the product ranges. Proficient in the use of Access-based databases for data storage, retrieval and analysis, and at writing reports based on these data.
- Production of copy for online and print publications targeted to wide range of audiences – including, but not limited to, press releases, blog articles, and webpage content – supporting new product launches as well as raising awareness of existing products and services.
- Five years’ experience of Regulatory Affairs and Pharmacovigilance: part of nine years’ overall experience of the pharmaceutical industry
- In Regulatory Affairs role:
- Wrote and edited documentation for Marking Authorisation applications, variations, and renewals, including line extensions, copycat applications and updates to SPCs and product literature;
- Formed good working relationship with regulators in National and European Authorities, enabling regulatory and pharmacovigilance procedures to run smoothly from beginning to end;
- Oversaw clinical trials for post-marketing safety assessments and co-ordinated clinical trials applications with external research organisations.
- In Pharmacovigilance role:
- Wrote Periodic Safety Update Reports, Controlled Safety Data Sheets, as well as Risk Assessments, and Clinical/Safety Expert Statements;
- Acted as Deputy QPPV: responsible for writing/updating SOPs, and training staff across EU in Regulatory and Pharmacovigilance requirements and procedures;
- Managed recall procedure following incident at third party distributor, including liaison with UK, US and Irish colleagues across all involved departments;
- Coordinated preparations for routine Pharmacovigilance Inspection, oversaw inspection, initiated follow-up: received glowing report from the inspection team;
- Acted as company representative on National Office of Animal Health PV Group.
- While working in Medical Communications and Education role, set up meetings and advisory boards for Key Opinion Leaders and client companies, as well as producing meeting minutes.
- IT skills include daily use of Word and Outlook; frequent interrogation of online information services such as PubMed; regular use of Excel, and Access-based databases.
Additional Information: Volunteering
- I run a local Brownie Unit, and take part in regular training and leadership events provided by Girlguiding UK to further enhance my people management and teambuilding skills.
- I am also involved in Community Action projects through Broadlaw Walk Community Space, including helping with the Summer and Christmas Fairs, and the new Mosaic Project to involve local residents in designing a new outdoor space around the new flats and shopping precinct.