Principal Scientist

Responsibilities:

In conjunction with PVRM Lead, perform safety surveillance activities within a product(s) team that include:

Signal Detection and Medical Surveillance Activities.

• Independently evaluates data, identifies opportunities and risks, weighs alternatives and presents analyses to Medical Director for review.
• Organize planned and ad hoc safety review activities - Obtain data for signal assessment (e.g., Oracle AERS, FDA AERS data, literature search); generate/request listings, identify cases, prepare initial assessment for review and finalization by Medical Director, follow-up on meeting outcome (as needed), ensure the appropriate maintenance of relevant documentation.
• Quarterly AE Review of Clinical Trials - Perform first iteration of listings review, discuss issues with Medical Director.
• Lot Review - Prepare listing and table for Medical Director review and summary.
• Literature Surveillance - Perform review of literature with appropriate documentation; identify case reports as well as new safety information and alert Medical Directors, as appropriate.

Risk Management/Post-Approval Commitments.

• Under supervision of the Medical Director, contribute to creation, annual review and update of RMPs as needed.
• Follows up on safety related post-approval regulatory commitments for assigned products.

Aggregate Reports

• PSURs.
• Draft/Collect Sections 1 through 8
• Work with others to determine topics for discussion in Section 9; prepare first draft of Section 9 for Medical Director review.
• Follow-up on issues identified in regulatory responses (e.g., assessment reports).
• US Periodic Reports – Obtain data and develop first draft.

Clinical Trial Support

• Oversee and perform case processing activities working with CTSA to ensure consistency, as needed.
• Investigator Brochure (IB): Contribute to creation, review and updates of IB.
• Aggregate Reports for investigational products such as DSURs, ASRs, IND Annual - collect, collate, format and draft PVRM data contribution.
• IND Safety reports - analysis of similar events - Collect, collate, format and draft data contribution and perform first review.
• Database Lock - Perform reconciliation and signoff.
• Clinical trial safety review.

Regulatory

• Regulatory Requests/Responses - Pull data and draft response in consultation with Medical Director prior to management review.
• Submissions - Contribute to creation and review of 2.5, 2.7.4 of CTD; Integrated Summary of Safety; proposed labels for submissions.
• Manage pharmacovigilance related activities associated with proposed safety label changes.

Other

• Effectively manages department workload and product responsibilities.
• Manage respective outputs for assigned product(s) ensuring on-time delivery of quality documents. Ensures timely decision-making, problem solving, follow through and appropriate managerial elevation of issues.
• Represents functional area on routine issues and facilitates multidisciplinary communications.

Minimum Education, Experience, Knowledge and Skills Required:

• Master Degree or PhD in Medical Science, Pharmacy or Nursing preferred.
• Minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in a clinical safety or regulatory affairs departments required.

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SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.