Safety Evaluation and Risk Management, Principal Scientist
il y a 1 semaine
About the role
Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.
Ensures 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. 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. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.
About the responsibilities
1. Scientific/Medical Knowledge PV Expertise
Responsible for signal detection and evaluation activities for assigned products. Ensure that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data. Assist in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel. Author regulatory periodic reports and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports. Act as a member of a process improvement initiative team within GCSP. Complete any post audit/inspection activities within the required timeline Use a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of SERM physician. Show commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to prioritise own workload with minimal guidance.2. Cross-functional Matrix team leadership
Build effective working relationships and responds to the needs of line functions in the matrix in relation to safety issues. Support 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 approiately in clinical study protocols and/or product labelling. Handle mentoring of junior SERM colleagues, can contribute to evaluating the activities of junior colleagues. Can explain knowledge and skills, and work in new situations. Early capability for Safety Lead role.3. Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
Share ideas with line manager on ways to improve processes for assigned tasks. Able and willing to adjust behaviours and priorities based on changing environment. Able to deal with ambiguity and resilient, focused, and optimistic under pressure. Show effectiveness in both oral and written communication. Able to effectively express ideas and incorporate feedback into deliverables to create a quality output. Demonstrate thorough medical/scientific writing skills are important, as the preparation of detailed evaluations and reports is a core feature of the role. Support a safety risk positions Keep manager/supervisor informed of progress and activities; escalates issues as appropriate Able to present merits of own point of viewAbout you
Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pham D). Advanced degree preferred. Relevant 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
#GSKVaccine
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 ahead of disease together.
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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
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