Senior Director, Technology Enabled Services
IQVIA
SERM Director – Safety Scientist
GSK
full-time
Posted on:
Location Type: Office
Location: London • 🇬🇧 United Kingdom
Visit company websiteJob Level
Lead
About the role
- Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.
- 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
- 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.
Requirements
- 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.
- Excellent communication (verbal, written) and influencing (internally and externally) skills.
- Proven ability to affect department, or product strategies with a strong understanding and ability to incorporate global considerations into decision making.
Benefits
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, Dentists and Veterinarians are also accepted).
- Comprehensive experience in the Pharmaceutical or Biotech industry working in Drug Safety or Pharmacovigilance
- Significant 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
safety evidence generationbenefit-risk assessmentcausality assessmentevaluation of safety signalsrisk management strategiesregulatory safety reportssignal evaluation methodologysafety review processsafety issue managementlabelling changes
Soft skills
sound judgementdecision makingcoachingmentoringcommunication skillsinfluencing skillsstrategic thinkingproactive risk managementcollaborationproblem solving
