Safety, Evaluation
il y a 4 semaines
**Site Name**: Belgium-Wavre
**Posted Date**: Nov 19 2024
**Job purpose**:
Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Make recommendations for the further characterization, management, and communication of safety risks.
Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
**Your responsibilities**:
Scientific/Medical Knowledge PV Expertise
- Responsible for signal detection and evaluation activities for assigned products.
- Drive production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).
- Author the SERM safety contribution to global regulatory submissions in partnership with the product physician.
- May respond to auditors/inspectors’ requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.
- Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.
- Make sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identify, evaluate, and recommend solutions to problems.
- Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.
Cross-functional Matrix team leadership
- Support and Facilitate safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
- Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.
- May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
- Build strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.
Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
- Present complex issues to senior staff members at the GSK Senior Governance Committees.
- Demonstrate initiative and creativity in performing tasks and responsibilities. Proactively contribute ideas to improve existing operations.
- Proactively contribute ideas to improve existing operations.
- Participate in process improvement initiatives within GCSP and contribute to advancement of methodology and process by generating new ideas and proposals for implementation.
- Possess effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listen and respond appropriately to the views and feedback of others.
- Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.
- Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective.
**_ Why you?_**
- We are looking for professionals with these required skills to achieve our goals:_
- Medical Doctor (physician) preferred, (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
- Substantial experience in pharmacovigilance or drug development.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
- Experience working in large matrix organizations.
Li-GSK #GSKVaccines
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
**Why GSK?**
**Uniting science, technology and talent to get a
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