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Senior Manager, Global Risk Management & Benefit Risk Evaluation

Perrigo

Nazareth, Belgium

Your responsibilities:

Act as Internal & External Safety Expert:

  • You lead Global Pharmacovigilance projects and drive them to completion;
  • You provide PV and risk management expertise to internal and external customers;
  • You act as a safety expert for our medicines;
  • You maintain knowledge of product, product environment and recent literature;
  • You ensure appropriate search terms are selected for our medicines portfolio;
  • You maintain PV expertise, understanding and updated knowledge of international safety regulations and guidelines;
  • You ensure appropriate vendors are selected & qualified for its safety purpose;
  • You ensure appropriate KPIs are implemented where appropriate.

Risk Assessment/Risk Management/Benefit-Risk Assessment:

  • You provide proactive risk assessment;
  • You develop risk management strategies and plans and monitor effectiveness;
  • You co-lead benefit-risk assessment with other relevant functions (QPPV, Safety medical review).

Signal Detection:

  • You are co-responsible for the preparation work in relation to signal detection, triage;
  • You co-lead signal management process with other relevant functions (QPPV, medical review);
  • You coordinate the preparation meetings & acts as the spokesperson through the agenda of Risk Management Steering Group;
  • You manage cumulative safety planning in accordance with timelines as mentioned into signal management procedure;
  • You maintain the oversight of signals.

Report Writing:

  • You will document, write, coordinate, review and validate periodic reports such as PBRER, RMP, ACO and other related safety documents;
  • You ensure generation, consistency, and quality of safety sections in submission documents;
  • You train & supervise PV officers in the data collection and the QC of safety documents;
  • You discuss the content and strategy of safety documents with important stakeholders (QPPV, Global Regulatory Affairs, Safety Medical review);
  • You write responses or contributions for the health authorities related safety enquiries;
  • You work with a cross functional team to realize deadlines for health authority requests and submissions;
  • Ensure that safety documents (e.g. periodic reports, signal evaluations, regulatory enquiries, risk management plans) are written accurately and in a timely manner to meet global compliance and regulatory requirements.

CDS/CSI:

  • You will be safety responsible for the project of the implementation/development/update of CDS/CSI for Omega medicines portfolio;
  • You have experience in writing and management of CDS/CSI.

Your profile:

  • Life science degree (pharmacy, medicine, …) or equivalent through experience;
  • You have at least 5 years of significant and successful experience in international Pharmacovigilance with 3 years in Risk management Job and/or safety documents writing;
  • Previous line management of small teams would be advantageous, however candidates with mentoring experience will be considered & who wish to develop their line management skills;
  • Experience in medical writing is an asset;
  • Highly analytical, process minded and detail oriented;
  • Be able to work in a matrix environment whilst remaining organized at all times;
  • You demonstrate initiative and capacity to work under pressure;
  • You have a hands on-mentality and a proactive attitude;
  • Your are fluent in English and have excellent communication skills. Knowledge of other European languages is an asset;
  • You will act on a 24h basis in providing scientific expertise in order to support urgent safety restrictions and product recalls;
  • You are a true team player and demonstrate leadership within cross-functional team environment.

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