One of Real Staffing's clients, a top biotechnology firm headquartered in Cambridge, Massachusetts, could be a fantastic new step in your career!
The role is a 6 month contract with ample opportunity for extension or full-time conversion at the client site.
Your Title: Senior Manager / Drug Safety
You will serve as a product lead for Pharmacovigilance activities within the SABR (Safety and Benefit Risk Management) Medical function. The Senior PV Scientist team is 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. You will also serve as a Subject Matter Expert for SABR and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.
Your Responsibilities, Broken Down by Percentage:
30% - Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Lead the signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information. 30% - Collaborate with Global Safety Officers and other SABR 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.
20% - Leads process for responding to safety questions from regulatory authorities. 10% Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions. 10% - Leads and collaborates with Aggregate Reports on 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).
Why Join Us?
Real Staffing is one of the US's top five Life Sciences recruitment agencies. With a global presence and a client portfolio built on trust and exceptional services, our aim is to bring skilled people like yourself together with fantastic opportunities to build the future.
Our client is a biotechnology firm that has made incredible growth and is well-funded, with a culture of collaboration, success, and courage - empowering employees to work fearlessly!
Sthree US is acting as an Employment Business in relation to this vacancy.