Company: Hydrogen Group
Closing Date: 21 Feb 17
Salary (£): Negotiable
Brand Leader- Global Drug Safety (GDS)
Brand Leader- Global Drug Safety (GDS) is to ensure effective proactive medical safety strategies for the assigned development compound(s) and/or marketed product(s)' delivery of safety aspects for clinical development' and risk management and benefit-risk evaluation. Includes delivery of the medical evaluation of single case safety reports based on medical judgement and clinical experience, safety signal detection and evaluation activities, periodic safety reports, risk management plans and regulatory documents, ensuring definition, implementation and evaluation of risk mitigation activities, and delivery of safety aspects of clinical trial activities as appropriate. You will act as a member of a Global Product Team (GPT) or Life cycle management team and provide a single initial point of contact within GDS for all, or specific assigned, aspects relating to the safety of the product.
You will engage discussion with the Medical Safety and Ethics Board and GDS Senior Medical Board for specific topics for your assigned product(s) thereby representing Merck and safeguarding our patients.
Who you are:
* Several years of medical experience as a physician
* Broad industry experience (minimum 5 years), preferably including both clinical development and Post-marketing pharmacovigilance experience
* Excellent knowledge of product development process and experience of cross-functional team work.
* Preferably prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
* Firsthand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological)
* Professional experience in an international environment
* Excellent medical judgment in safety decision-making
* Strong, mature project leadership and influencing skills
* Entrepreneurial thinking and striving to move project(s) forward, within budget and timelines
* Strong team player and excellent networking skills
* Proven ability to chair meetings effectively
* Solution and results orientated
* Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets
* Excellent verbal and written communication skills (in English language)
30 Eastcheap London
|Tel:||+44 (0) 207 002 0000|
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