SERM Associate Scientific Director

GlaxoSmithKline; City Of London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in London is seeking a SERM Associate Scientific Director to provide medical expertise in safety evaluation and risk management for key assets. This role involves regulatory reporting, signal detection, and collaboration with cross-functional teams to ensure patient safety. Ideal candidates will have a health sciences degree and experience in pharmacovigilance.

Benefits

Competitive salary

Annual bonus based on company performance

Healthcare and wellbeing programs

Pension plan membership

Shares and savings program

Hybrid working model

Qualifications

• Experience in safety evaluation and risk management.
• Knowledge of international pharmacovigilance requirements.
• Experience working in large matrix organizations.

Responsibilities

• Responsible for signal detection and evaluation activities.
• Drive production of regulatory reports and documentation.
• Support safety governance in clinical development.

Skills

Pharmacovigilance experience

Medical/scientific writing skills

Effective communication skills

Education

Health Sciences/Health Care Professional degree

Job description

Overview

We are looking for a SERM Associate Scientific Director to join our team. This position supports the HIV Therapeutic Area. As the successful candidate you will provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in the post-marketing setting and late stage clinical development. Ensure scientifically sound review and interpretation of data and management of safety issues and escalate 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.

Responsibilities

• 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; advises on content of regulatory period reports (in partnership with the product physician).


• Prioritise activities effectively to meet multiple deadlines successfully with appropriate attention to detail, setting high performance standards for quality.


• 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 to detect and address product safety issues and ensure that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.


• 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 be capable of presenting ideas and data clearly and concisely to a matrix team as well as to senior staff members at Governance Committees, with the ability to listen and respond appropriately to the views and feedback of others.

Qualifications

• Health Sciences/Health Care Professional degree (or equivalent) required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred.


• 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


• 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.

Preferred Qualifications & Skills

• Prior experience in the HIV therapy area is desirable but not essential

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the CMS website at https://openpaymentsdata.cms.gov