patient safety officer
- Maatrom Solution
- 3 to 8 Yrs
- Multi-City, India
- 3 years ago
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Job Description
Main responsibilities and tasks:
This requires effective medical, technical and scientific expertise in safety data collection, evaluation, medical interpretation and communication.
- Accountable for the conduct of safety surveillance and assessment of integrated safety information, to ensure the timely proposal of changes to the safety profile and appropriate risk management and risk minimization actions, in order to warrant the safe and effective use of Ipsen product in development projects and on the market.
- Ensure effective proactive continuous management of the safety profile for assigned development compounds and marketed products, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met.
- Act as a member of the Global Product Team and Clinical Development Team for one or more products, as required and as delegated by the respective GPS TA Leader, and as such be the contact person for relevant safety-related deliverables, issues and questions in relation to this (these) product(s).
- Support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments.
Ensure proactive safety and risk management for all assigned products:
- Through an Integrated Safety Sciences collaborative approach, implement proactive safety and risk management strategies, agreed cross-functionally with product team colleagues for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions
- Ensure that clinical development plans/life-cycle mangement plans adequately address the safety questions and deliver the safety strategy for approval by safety governance
- Lead the development of the Risk Management Plan for assigned products as applicable
- Member of the Risk Minimisation Programme Team (leadership of this team may be delegated by the respective GPS TA Leader), and ensure the evaluation of the effectiveness of risk minimisation measures
Support safety decision-making for benefit-risk assessment:
- Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available data
- Provide medical support (and leadership as delegated by the respective GPS TA Leader) for all safety components of regulatory submissions, health authority safety-related questions, and periodic safety reports (PSURs, PBRERs, DSURs)
- Contribute effectively in internal interactions and cross-functional teams
- Deliver medical safety assessments as required, eg in the evaluation of the risk and impact of product quality complaints
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Allied Health ServicesPharmacist / Medical Representative
Functional Area: Not Applicable
Role/Responsibilies: patient safety officer
Contact Details:
Company: M/s Chauhan CraneLocation(s): Multi-City, India
Keyskills: pharmaceutical medicine drug interactions medical affairs pharmacy education pharmacovigilance dosage calculations pharmaceutical care prescription drugs decision-making team management
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