Senior Manager Healthcare & Clinical

This is an individual contributor position in the HIV Therapeutic Area and will serve as Safety Lead for a product.
Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) group and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.
As a senior member of the Global Safety organization the role is responsible to:
Implement policy, processes and support the implementation of operational and strategic plans
Ensure 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
Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Scientific/Medical Knowledge PV Expertise
Demonstrated record of sound judgement and decision making in safety evidence generation, benefit-risk assessment, causality assessment, evaluation of safety signals, and of proactive risk management strategies including management of labelling changes, physician and patient education and monitoring of safety issues in the real world.
Coaches and mentors SERM colleagues in the scientific/medical aspects of signal evaluation methodology and risk management and preparation of regulatory safety reports and other documents.
Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
Provides excellent medical/scientific judgment, strong analytical skills, proactive approach in drug safety and high sense of urgency.
Anticipates, detects and addresses product safety issues and ensures that risk-reduction strategies are implemented appropriately.
Leads cross-GSK activities such as safety advisory panels, interfaces with and assumes ad hoc membership of a Senior Governance Committee.
Leads cross-GSK activities such as safety advisory panels, interfaces and assumes ad hoc membership of a Senior Governance Committee. Leads driving change until their implementation.
Medical degree for Senior Medical Director or Health Sciences/Health Care Professional degree (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D) for Senior Scientific Director
Comprehensive experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance or Drug Safety
Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
Prior experience in the HIV therapy area is desirable but not essential
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).
Where they can keep growing and look after their wellbeing. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
We believe in an agile working culture for all our roles.Adjustments@gsk.00noon Monday to Friday, during bank holidays these times and days may vary.
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