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PV Operations Manager (contract), Drug Safety & Pharmacovigilance The contract PV operations Manager will provide ICSR case processing and medical review oversight in collaboration with PV vendor, DSPV Safety leads, Safety Scientist and Medical monitor in order to ensure timely and quality ICSR case processing from on-going clinical trials. In collaboration with PV Operations Senior Director, the contract PV Operations Manager will support of the management of Safety database through a PV vendor, ICSR medical review oversight, ICSR quality checks and documentation of findings/trends and triage of the DSPV safety mailbox with emphasis on global regulations. This individual must effectively interface cross-functionally at all levels within the organization including, but not limited to; Pharmacovigilance team, Clinical Operations team, Regulatory affairs team, Quality organization and cross functional teams for clinical development programs. Additionally, communicate effectively to external stakeholders, investigators, vendors, and Regulatory Authorities. He or she will collaborate with the Senior Director of DSPV Operations and attend clinical study team (CST) meetings for on-going clinical trials for assigned products. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. This role requires strong clinical/patient care experience, project management, written and verbal communication skills and will have the following responsibilities including, but not limited to:

• Develop medical review strategy for ICSRs for the clinical trials across platform in collaboration with PV operations, Safety surveillance team and CRO.
• Provide oversight of ICSR medical review in collaboration with CRO medical reviewer and internal Safety and medical colleagues as required.
• Manage safety database through PV vendor.
• Collaborate with PV operations team and PV vendor to ensure timely and high quality ICSRs from intake to submission.
• Represent DSPV in various cross-functional teams (e.g., Clinical Study Team, Medical Monitoring Meeting)
• Ensure that safety reports are triaged, scheduled, processed, and reported accordingly per global requirements and internal SOPs
• Provide day-to-day interaction with internal vendors under the direction of DSPV Operations management as related to case processing.
• Collaborate with PV vendor, clinical studies vendor(s) and regulatory operations to ensure quality and compliance for safety reporting (e.g., KPI)
• Communicate with partner companies, vendors, and internal groups regarding processing and timely exchange of safety reports under direction of DSPV Operations Director
• Support development and implementation of Safety Management Plans for study specific workflow between the company and CRO(s) (clinical research organization)
• Assist in development, contribute, review, and maintain up to date safety case processing SOPs, forms etc.
• Represent DSPV Operations in study management teams for assigned products, as needed
• Assist with reconciliation of safety data with data management and business partners as applicable

About You:

• Experienced safety professional (RN, PharmD)
• Solid clinical experience from direct patient care
• 7+ years of experience in drug safety and pharmacovigilance in medical review/ICSR case processing and PV operations from novel clinical development programs.
• You are to lead and work in a fast paced, growing drug safety & pharmacovigilance department where your knowledge and hands-on experience of the good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines for ICSR case processing including intake, medical review and regulatory submissions.
• You have knowledge of MedDRA dictionary and strong case processing, and narrative writing skills
• Experience with software-based drug safety systems (ARGUS, ARISg or equivalent)
• Strong computer skills (MS Office).
• Prior experience with gene therapy products or biologics and direct patient care experience as a clinician will be a plus.

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. Company Profile: Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you! Beacon Hill. Employing the Future™