Your new company
My client is a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life. There is an opportunity for an Associate Director, Safety Science to join their pharmacovigilance team.
Inside IR35
Remote working (must be currently living in the UK)
Your new role
The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with a cross-functional team to evaluate safety signals.
* Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting.
* Assist in follow-up of important ICSRs to ensure relevant information is sought.
* Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals.
* Participate in the development of safety surveillance and risk management plans for drug development programs.
* Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR (PBRER format), US PADER, Annual Safety Report, DSUR, IND Annual Report).
* Serve on the Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organisations (CROs), Data Monitoring Committees and other entities as needed.
* Participate in the preparation and revision of company product labelling and RMP as appropriate.
* Assist with the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents.
* Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.
What you'll need to succeed
BSN, RN, PharmD, MD, DO or equivalent.
Strong Pharmacovigilance and safety science experience, including aggregate safety data review, production of periodic reports, ICSR medical review, authoring health authority responses, representing Global Patient Safety in cross-functional meetings and external engagements, etc. With hands-on experience in a Safety Science role and having performed the tasks outlined within a pharmaceutical company.
Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format
Knowledge of common safety database systems.
Strong organisational skills, including the ability to prioritise independently with minimal supervision.
Excellence in communication
Strong innovation, decision-making and problem-solving skills
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292