Serm Associate Scientific Director - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
Belgium-Wavre

Posted Date:
Apr

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.

What will be some of your responsibilities ?:
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 crossfunctional teams in any SERM to detect and address product safety issues and ensures that riskreduction strategies are implemented appropriately in clinical study protocols and/or product labelling
Lead or participate in crossfunctional 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

Why you?:

Basic Qualifications:

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 postmarketing 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.

Communications and Influencing abilities:

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
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

LI-GSK

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.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholde