• Job Description

  Req#: 379407

  Bringing together more than 300 products, including best in class, first in class, growth and pipeline assets, our pharmacovigilance Specialty/General Medicines portfolio represents an incredible opportunity to impact the lives of 700+ million patients in the next 10 years. Many of the GSK heritage brands we manage are the leader in their therapy area or even the number one pharmaceutical brand on the market. We provide pharmacovigilance and comprehensive benefit-risk management for advanced Respiratory medicines and devices, Allergy/immunoinflammatory and Dermatology, Neurosciences, Anti-infectives including anti-microbials, antivirals (ViiV Healthcare) and antimalarials, Urology, CV/Metabolic, Hepatology and many more! Product support ranges from R&D into Post-approval, Established & Generics.

  SERM/TERM Associate Medical Director

  This role has the following important purpose: Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets 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.

  This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Scientific/Medical Knowledge PV Expertise: Responsible for signal detection and evaluation activities for assigned products. Drives 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). Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician

  • Cross-functional Matrix team leadership: Supports and Facilitates 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. Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency

  • Communications (verbal, written) and Influencing (internal PV Governance and External LTs): Presents complex issues to senior staff members at the GSK Senior Governance Committees. Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes ideas to improve existing operations.

  Why you?

  Basic Qualifications:

  • Medical Doctor (physician) with additional relevant medical or scientific post-graduate qualifications.

  • Substantial 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 and fluent in English

  Preferred Qualifications:

  • Communication skills and team player

  • Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective

  Why GSK?

  What we offer

  • Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs)

  • Contract of employment

  • Flexible working hours

  • Established job in an international, well-known pharmaceutical company

  • Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market

  • Opportunity to work within GSK standards and documentation applied globally

  • Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, Company Car)

  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement)

  • Possibilities of development within the role and company’s structure

  • Personalized learning approach (mentoring, online training’ platforms: Keep Growing Campus, LinkedIn Learning, 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 every day

  #LI-GSK

  #LI-Hybrid

  ?GSK is an INCLUSIVE and DIVERSE employer. If you require any adjustments during recruitment process let us know: pl.recruitment-adjustments@gsk.com .

  Why Us?

  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 organization 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.

  If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

  GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

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