Medical/Clinical Advisor

AbbVie

Wiesbaden, Germany

The purpose of this role is to support the International/EU QPPV in meeting their regulatory PV obligations, ensuring oversight of AbbVie’s PV system and the products support by it. Key responsibilities include delegated QPPV review of periodic safety reports (PSUR, DSUP), RMPs, PASS protocols and emerging PV legislation. As part of the Office of the QPPV, the incumbent will also be responsible for sharing relevant product safety, risk management and PV policy information with Affiliate PV staff globally.

Responsibilities:

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.

Qualifications

Bachelor’s or master’s degree in relevant biological science, healthcare discipline (medicine, pharmacy or nursing) or pharmacovigilance.
At least 5 years in regulated pharmaceutical industry; must have comprehensive working knowledge of EU PV legislative framework and practical experience of reviewing PV safety deliverables.
Influences colleagues to achieve cross-functional alignment.
Adaptable and strong problem-solving abilities.
Motivational approach, open to new ideas and the ability to connect the dots within and across groups and functions.
Excellent written and verbal communication skills in English.

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