Clinical Safety Manager will support medical surveillance activities and maintain oversight for the Pharmacovigilance (PV) function for the clinical program. The incumbent is expected to work cross-functionally with key internal and external key stakeholders and resources on pharmacovigilance-related matters.  In addition, represents the Pharmacovigilance department on clinical project meetings and manages all clinical trial activities relating to drug safety.

Responsibilities:

• Work cross functionally with clinical team (Clinical Operations, Development, Data Management, clinical CRO/vendors, Regulatory) to ensure PV requirements are met and mechanism are in place to ensure safety oversite and global regulations are met.
• Participates in study initiation including but not limited to: safety reporting, query resolution, SAE reconciliation, un-blinding process, and Investigator safety reporting training. This can include authoring of safety management plans and review of the following: protocol, Informed Consent Forms, Data Management Plan, Medical Monitoring Plan, DSMB charter etc.
• Responsible for Transfer of Regulatory Obligation and budget review and will review and approve clinical CRF design- specifically for AE and SAE capture.
• Lead author for DSUR reports and for managing AEs/SAEs originating from clinical program (clarify medical issues, issue queries, confirm case assessments, ensure clear narratives, revise MedDRA terms, and coordinate with external vendors and internal medical personnel as needed).
• Train, mentor and provide guidance to clinical sites, PV and other support staff and vendors to ensure safety reporting obligations are clear and met.  Ensure all assigned projects follow company standard procedures and global regulations/best practices.
• Develop and/or update Standard Operating Procedures, Working Instructions, and training materials. Demonstrates understanding of all clinical and post-marketing activities and PV requirements. Effectively manage to ensure compliance with regulatory submissions and internal timelines.
• Participates in audit preparedness activities and serves as subject matter expert during regulatory inspections. Assist in performing investigation of deviations and monitoring of Corrective Actions/Preventive Actions (CAPAs) relating to non-compliance issues and findings, as well as assess the effectiveness of the CAPAs.

Qualifications:

• Minimum of Bachelor of Science degree required; preferred in chemistry/biochemistry disciplines.
• 6+ years of pharmacovigilance/drug safety experiences and clinical experiences.
• Health care professional preferred.

The range of starting base pay for this role is 124K – 171K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes comprehensive Medical (includes Prescription Drug), Dental, Vision,  Flexible Spending Accounts, 401(k) with matching company contribution, 3-weeks paid time off plus paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- and long-term disability,  life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), employee referral bonuses and employee discounts.

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