Are you an experienced Senior Pharmacovigilance Scientist? Are you interested in overseeing and leading the process for safety signal management activities and aggregate reports? If so, we would love to speak with you.
We are hiring for a Senior PV Scientist to join a globally leading Biotechnology client of ours, ensuring products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensuring the marketing authorisation remains in good standing.
The successful candidate will be responsible for acting as product lead for Pharmacovigilance activities within Safety. You will also be responsible for overseeing and leading the process for safety signal management activities, aggregate reports, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.
This is a contract position, offered initially for 12 months working 37.5 hours per week based in Maidenhead. (Inside IR35).
Responsibilities:
Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
Synthesis of data from multiple sources and authoring signal evaluation reports.
Leads signaling review process and product Safety Signaling Team meetings.
Manages literature review for safety information.
Leads process for responding to safety questions from regulatory authorities.
Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.Experience and skills:
Bachelor's Degree in biologic or natural science, or health case discipline and/or advanced degree (PhD, MPH, NP, PharmD, etc.)
Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format.
Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations.
Knowledge of case processing, expedited reporting rules, and safety database concepts.
Knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Knowledge of common safety database systems.
Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
Strong organizational skills, including the ability to prioritize independently with minimal supervision.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business
