SERM Principal Scientist

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.Mentors junior SERM colleagues, can contribute to evaluating the activities of junior colleagues. Explains knowledge and skills, and work in new situations.

In this role you will be responsible for …

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

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.

Communications (verbal, written) and Influencing (internal PV Governance and External LTs)

• Shares ideas with line manager on ways to improve processes for assigned tasks.
• Keeps manager/supervisor informed of progress and activities; escalates issues as appropriate.
• Able to present merits of own point of view.

Why you?

We are looking for Candidates with substantial experience in pharmacovigilance or drug development:

• Health Sciences/Health Care Professional with advanced degree
• Pharmacovigilance experience relating to Safety Evaluation and Risk Management in post-marketing activities
• Knowledge/experience of international pharmacovigilance requirements and drug development
• Experience working in large matrix organizations
• Proficient in written and spoken English

Preferred Qualifications

• A post graduate qualification (e.g. Master, PhD etc.) would be desirable
• Industry experience – especially multi-function experience e.g. clinical safety + medical affairs/clinical development would be ideal
• Thorough medical/scientific writing skills are important, as the preparation of detailed evaluations and reports is a core feature of the role
• Ability to adjust behaviors and priorities based on changing environment
• Effectiveness in both oral and written communication

Why GSK?

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible counterparts
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits everyday
• Free car and bike parking, locker rooms and showers

#LI-GSK

#LI-Hybrid

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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