Job Summary

Senior Manager - Drug Safety serves as a product lead for Pharmacovigilance activities within the SABR 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. The Senior PV Scientist also serves 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.



Accountability Descriptions



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. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.


Global Safety Officer


SABR MDs


Epidemiology




30% - Collaborates 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.


Global Safety Officer


SABR MDs


Clinical Development


Global Clinical Operations


Regulatory



20% - Leads process for responding to safety questions from regulatory authorities. Global Safety Officer


SABR MDs


Regulatory


Epidemiology


Biostats



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.


Associate Director / Director PV


SABR Compliance



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).


Sr PV Scientist / PV Scientist (Aggregate Reports)


Global Safety Officer


SABR MDs


SABR Compliance



Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.




* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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