Medical Advisor (all genders)

at  AbbVie

COMPANY DESCRIPTION

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description

• Conducts medical review of aggregate and ad hoc safety reports (e.g., PSUR, DSUR, RMP and MSA) and provides QPPV advisory support to Product Safety Team as necessary. Reviews and communicates regulatory assessment report feedback to relevant stakeholders and informs QPPV of assessment recommendations.
• Maintains oversight of regulatory RFIs and ad hoc safety issues arising from AbbVie’s internal safety surveillance activities. Provides QPPV advisory input, as necessary, to inform response strategy.
• As part of the QPPV office, provides 24/7 assistance to the International/EU QPPV as requested and acts as the EU QPPV back-up during periods of absence.
• Works in close collaboration with Area PV Leads to communicate and execute product PV strategies across AbbVie affiliates.
• Supports preparation and maintenance of QPPV Office website content to facilitate timely communication of relevant product safety and risk management updates to Affiliate PV staff.
• Supports the development of product-specific launch excellence training materials and ASR and National QPPV training program content.
• Active member of PST meetings and contributes to safety deliverables, providing product PV and regulatory safety action updates.
• Contributes to periodic QPPV Network oversight meetings, providing product PV and regulatory safety action updates.
• Contributes to QPPV oversight/ governance meetings; includes agenda item development and recording of meeting minutes/actions.
• Reviews emerging PV legislation and policy; assess and communicates potential impact on PV system and processes to International / EU QPPV and functional BPO/SMEs. Partners with RPI PV Director to develop and execute AbbVie PV Advocacy plans.
• Supports periodic review and QC of PSMF core content and supporting annexes. Works closely with PSMF Quality Systems Manager to address any PSMF related issues or requests.
• Works with Safety Compliance colleagues to maintain QMS documents (Policies, SOP and WI), relating to QPPV responsibilities and activities.
• Provides ad hoc medical support to EU QPPV and represents EU QPPV/Office of the QPPV on designated special projects