Manager, Drug Safety and Pharmacovigilance

Position Summary:

Responsible for providing medical expertise regarding the safety and risk assessment for Client products at all stages of the product life cycle (development to post-marketing).

Responsible for ensuring that the safety data are evaluated medically and put into context in order to support risk assessment and contribute to benefit-risk assessment.

Responsible for performing medical assessment, medical review and signal detection/evaluation activities as well as for drafting risk communications and contributing to safety sections of safety and non-safety documents.

Primary Responsibilities:

Medical review of Individual Case Safety Reports (ICSRs) for assigned product(s) to ensure accuracy, integrity and completeness of safety information including providing company causality as required.

Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, and ad hoc safety assessments.

Work in close collaboration with cross-functional teams and counterparts in regulatory labeling, clinical development, pre-clinical, manufacturing/quality, and other functional areas to identify, evaluate, and communicate safety issues, as assigned.

Provide support for the safety aspects for clinical studies, and development and maintenance of the company core safety information.

Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents as needed.

Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.

Author analysis of similar events (AOSE) and individual case comments for ICSRs.

Maintain knowledge of global regulatory authority regulations including FDA and EMA.

Other duties as assigned.

Product:

Supports the development of strategic plans for Pharmacovigilance and participates with others in management to align objectives across the organization.

Works on complex medical issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.

Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the company.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations.

Employee must occasionally lift and/or move up to 20 pounds.

Experience/Skills:

Minimum of 3-5 years of experience in the role of safety officer or similar pharmacovigilance role in the pharmaceutical industry.

Experience in the management of safety information originating from both clinical trials and post-marketing sources.

Thorough understanding, ideally based upon direct experience, of contemporary approaches to signal management, including quantitative signaling software.

Working knowledge of the regulations governing pharmacovigilance.

Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.

Excellent oral and written communication skills.

Excellent analytical skills and ability to work independently and as part of a cross-functional team.

Strong interpersonal, negotiating, and team building skills.

Demonstrated ability to formulate a credible medical opinion for presentation to management for action.

Proficient computer

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