Fladger Associates

 


Pharmacovigilance Clinical Safety Manager

Responsibilities:

  • Excellent employment opportunity for a Pharmacovigilance Clinical Safety Manager in Wilmington, DE area

  • Responsible for the reviewing, reporting and tracking of adverse drug experience reports, manage the preparation of aggregate (DSUR, 6-month SUSAR LL and ad-hoc) reports, and all aspects of Pharmacovigilance Compliance regarding late cases to agencies and licensing partners.

  • Collaborate with internal departments to support and develop standard operating procedures/working practices/collection forms and adheres to company and departmental SOPs as required.

  • Coordinate the timely completion and submission of required reports to health authorities and business partners.

  • Ensure all adverse event reports made to company or contracted safety vendor acting on behalf of company, are triaged, scheduled, processed and reported according to SOPs and Work Instructions.

  • Assist with creating policies, SOPs, work instructions, forms and templates for efficient and effective processing of ICSRs and aggregate reports.

  • Ensure company procedures are in compliance with all ICH-GCP guidelines, Federal Regulations, industry best practice, and agreements with licensing partners and/or regulatory authorities.

  • Track all cases to ensure adherence to processing timelines.

  • Manage relationships and daily operational issues with licensing partners.

  • Collaborate with Pharmacovigilance Medical Directors to ensure that medical review and documentation is provided for assigned cases and is in accordance with company SOPs and Work Instructions.

  •  Contribute to writing of late case investigations/identifying root cause including developing and implementing CAPAs (corrective and preventive actions).

  • Undertake ongoing performance review, feedback and development of staff.

  • Assist with talent recruitment and leads a highly motivated, efficient and effective team.

  • Responsible for training and mentoring safety systems associates on the Pharmacovigilance Operations team.

Experience:

  • To be considered for this Pharmacovigilance Clinical Safety Manager job opportunity a Bachelor’s degree in a science or healthcare related discipline.

  • Experience in a medical field (RN, pharmacy, PharmD, PA) preferred.

  • 6-8 years of drug safety experience in Pharmacovigilance; premarketing and/or post-marketing safety preferable or equivalent combination of some applicable pharmaceutical clinical trial experience.

  • Must be able to demonstrate strong knowledge of global clinical safety/Pharmacovigilance regulations, ICH guidelines and FDA/EMEA regulations regarding safety.

  • Previous experience with Argus safety database involving query/report generation and adverse event software is highly desirable.

  • Must possess excellent communication (verbal and written) and problem-solving skills.

  • Strong computer skills in drug safety applications, Microsoft Word, Excel, and Power Point.

  • Experience with Quality Management processes and compliance monitoring required.

  • Strong attention to detail in composing and proof-reading materials, establishing priorities, scheduling and meeting deadlines.

  • Experienced in reviewing aggregate reports (DSURs, PADERs and ad-hoc) for investigational products and marketed products is a must.

  • Project Management skills is must.

    Send Resume To info@fladgerassociates.net  and include Job Title In Subject Line