Gsk
Pharmaceutical
SERMMedicalDirector
“SERM Medical Director at Gsk. Skills: Pharmacovigilance, Risk Management, Safety governance. Provide medical/scientific expertise. Ensure scientifically sound review”
What You'll Achieve.
Meet needs of Patients; Meet needs of HCPs; Ensure Patient Safety globally; Improve adherence to regulations; Improve adherence to data standards; Improve adherence to quality; Improve adherence to efficiency
Industry & Context.
Creative problem resolution; Assessment of information; Understanding of wider context
What They're Looking For.
Must Have
Medical degree, Completion of postgraduate clinical training, Advanced experience in Pharmaceutical or Biotech industry, Experience in Pharmacovigilance or Drug Safety, Significant pharmacovigilance experience, Experience with Signal Detection, Experience with safety surveillance, Knowledge of international pharmacovigilance requirements, Knowledge of drug development processes, Knowledge of drug approval processes, Experience working in large matrix organizations
Nice to Have
Experience leading critical safety evaluations, Experience leading safety evaluation teams
What You'll Do.
Provide medical/scientific expertise
Ensure scientifically sound review
Escalate safety issues
Make recommendations for risk management
Support pharmacovigilance
Support benefit-risk management
Lead Pharmacovigilance Planning
Lead Risk Management Planning
Develop strategy for evaluation of issues
Lead safety component of regulatory submissions
Perform expert evaluation
Perform analytical thinking
Conduct literature review
Synthesize clinical data
Analyze clinical data
Interpret clinical data
Make quality decisions
Resolve problems creatively
Demonstrate multi-tasking skills
Explore positions and alternatives
Reach mutually beneficial agreements
Lead safety governance
Develop safety strategy
Execute safety strategy
Anticipate product safety issues
Detect product safety issues
Address product safety issues
Ensure risk-reduction strategies implemented
Facilitate safety governance
Assist in establishment of cross-functional teams
Assist in operation of cross-functional teams
Detect product safety issues
Address product safety issues
Ensure risk-reduction strategies implemented
Represent GSK on Clinical Matrix Teams
Represent GSK on Project Teams
Address urgent product safety issues
Address important product safety issues
Lead process initiatives
Participate in process initiatives
Drive efforts to improve adherence
Improve adherence to regulations
Improve adherence to data standards
Improve adherence to quality
Improve adherence to efficiency
Participate in SOP updates
Ensure policies are adhered to
Ensure regulations are adhered to
Accountable for issue escalation
Accountable for communication on safety matters
Build working relationships
Display leadership skills
Lead team in matrix setting
Lead presentations on recommendations
Lead presentations on safety issues
Interact with confidence
Interact with credibility
Interact with influence
Represent GSK at regulatory meetings
Contribute to safety discussions
Contribute to discussions with outside consultants
Contribute to discussions with other companies
Lead process improvement team
Consider internal environment
Consider external environment
Contribute to long-term strategy
Contribute innovative ideas
Improve approaches to operations
Lead inspection readiness
How You'll Work.
Team & Collaboration
Cross-functional teams; Clinical Matrix Teams; Project Teams; Cross-functional process initiatives; Cross-functional process Workstreams; Matrix team setting
Communication Scope
Verbal communication; Written communication; Influencing; Presentations; Senior governance committees
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