Senior Manager, Global Risk Management & Benefit Risk Evaluation
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).
- 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.
- 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.
- 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.
- 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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