Company: Mosaic Regulatory Solutions
Closing Date: 11 Nov 16
Salary (£): On Application
To apply for this PV / Risk Manager role you please call Julie Cooper on 07951 082482 to discuss. Otherwise please send in confidence your CV to: firstname.lastname@example.org
Role: Manager- Global Risk Management & Benefit Risk Evaluation
To strengthen our Safety Surveillance team, we are currently looking for a
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 medicines portfolio
You have experience in writing and management of CDS/CSI
In this role, you will be reporting to the Head of Global Safety Surveillance and supporting the EEA QPPV in maintaining the safety profiles of our medicines.
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 the capacity to work under pressure.
You have a hands on-mentality and a proactive attitude.
You 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.
A challenging role in a growing and dynamic global organization. Besides a competitive remuneration pack (including company car, pension plan, hospitalization insurance,…), we offer you a challenging role and interesting projects with an international scope.
Key word /key words- PV , Pharmacovigilance , QP , Drug Safety , Manager, Belgium , International , Risk Management role , CDS, CSI , safety , Risk Management , Report Writing
Mosaic Regulatory Solutions Ltd
|Tel:||0208 305 9733|
|Website:||Visit Our Web Site|
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