CHERCHEUR D'EMPLOI
Tableau de bord (nécessite d'être connectés)Safety Evaluation and Risk Management, Associate Scientific Director
- Secteur de mon entreprise
- Pharmaceutique
- Localisation de mon entreprise
- Wavre & Rixensart
- Adresse
Site de Wavre: Av. Fleming 20, 1300 Wavre
Site de Rixensart: Rue de l'Institut 89, 1330 Rixensart
Santé physique & mentale
About the role
The role of an associated scientific director is to provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting; and to 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.
But not only. An associated scientific director also makes 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, while supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
About you
Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred.
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
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
Build strong collaborative relationships and demonstrate good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others
Possess effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team
Demonstrate initiative and creativity in performing tasks and responsibilities
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
This role includes different aspects.
Scientific/Medical Knowledge PV Expertise
Be 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; advise 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
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 problem
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
Participate in process improvement initiatives within GCSP and contribute to advancement of methodology and process by generating new ideas and proposals for implementation
May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently