Site Name: GSK HQ, Belgium-Wavre, Canada - Ontario - Mississauga
Posted Date: Oct 11 2024
As SERM Associate Scientific Director you will provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
You will 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. As SERM Associate Scientific Director you will focus on efficiency and effectiveness to meet the needs of our Patients and Regulatory Authorities. You will be part of a team of physicians and scientists supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
In this role you will be part of a team supporting:
- Production of regulatory periodic reports and associated documentation globally according to the agreed process and timelines; advise on content of regulatory period reports.
- SERM safety contribution to global regulatory submissions, including RMPs.
- Safety governance/SRTs in the clinical development and post marketing settings to detect and address product safety issues.
- Ensuring risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
- Making recommendations for the further characterization, management, and communication of safety risks.
- Presenting complex issues to senior staff members at the GSK Senior Governance Committees.
Why you?
Basic Qualifications & Skills:
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Substantial experience in pharmacovigilance or drug development.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing clinical development and/or post-marketing activities.
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
- Ability to function successfully in cross-functional groups.
Preferred Qualifications & Skills:
- Experience working in large matrix organizations.
- Experience working globally in pharmacovigilance or drug development.
- IT competencies.
Closing Date for Applications – 25 Oct 2024 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
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 shareholder returns – as an organisation where people can thrive.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles.
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.