Job Purpose:
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.
Key Responsibilities :
1.Scientific/Medical Knowledge PV Expertise
Responsible for signal detection and evaluation activities for assigned products.
Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
Authors 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.
Acts as a member of a process improvement initiative team within GCSP.
Completes any post audit/inspection activities within the required timeline
Uses 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.
Shows commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to priorities own workload with minimal guidance.
2.Cross-functional Matrix team leadership
Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety issues.
Supports 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.
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)
Shares ideas with line manager on ways to improve processes for assigned tasks.
Ability and willingness to adjust behaviors and priorities based on changing environment.
Able to deal with ambiguity and resilient, focused, and optimistic under pressure.
Demonstrated effectiveness in both oral and written communication. Able to effectively express ideas and incorporate feedback into deliverables to create a quality output.
Thorough medical/scientific writing skills are important, as the preparation of detailed evaluations and reports is a core feature of the role.
Supports a safety risk positions
Keeps manager/supervisor informed of progress and activities; escalates issues as appropriate.
Able to present merits of own point of view.
Education Requirements :
SERM Principal Scientist
Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred.
Job Related Experience Requirements:
Relevant experience in pharmacovigilance or drug development.
Experience working in large matrix organizations
Scope of Accountability
Safety signal detection, assessment, and risk management. May chair Safety Review Team.
Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.
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.
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