Associate Medical Director/ Medical Director Global - Amersham, United Kingdom - GE HEALTHCARE

GE HEALTHCARE
GE HEALTHCARE
Verified Company
Amersham, United Kingdom

2 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

Primary responsibilities

  • Performs safety signal detection activities and/or works with PV scientists. Makes or suggests datadriven decisions throughout the safety signal workflow. Authors safety review documents and reports. Evaluates and make recommendations on actions arising from signals in collaboration with a crossfunctional Safety Review Team.
  • Prepares safety related content of documents generated during clinical development (e.g. clinical study protocols, DSUR, Development RMP, Safety Management Plans, clinical study reports) and post approval (e.g. PSUR, RMPs, medical expert statements).
  • Gathers and evaluates scientific information needed for development and maintenance of reference safety information in Company Core Documents (CCDS, CCSI).
  • Works with PV Scientists and provides medical input to responses to safety questions from regulatory authorities.
  • Prepares or facilitates writing of accurate, medically sound and submission ready statements, safety assessments and benefitrisk evaluations within agreed time frames.
  • Serves as a backup Medical Reviewer of certain Individual Case Safety Reports.
  • Serves as a Subject Matter Expert (SME) for Global Pharmacovigilance and crossfunctional teams on relevant ICH / EU / US / International (ICH) clinical and postmarketing safety regulations and guidelines; and productspecific information.
  • Other activities, special projects and assignments may be assigned where required. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting others with will vary depending on project assignments and the requirements within the department.

Qualifications / Requirements

  • Medical qualification as MD or equivalent (D.O., M.B.B.S, etc.), clinical experience is an advantage.
  • Experience in drug safety risk management and pharmacovigilance (safety signal detection, data mining techniques, preparation risk management plans, aggregate reports and company core safety information). Relevant experience in clinical development or medical affairs in industry or with service provider will be considered.
  • Working knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance.
  • Good medical writing skills and ability to analyze safety data.
  • Good communication skills.
  • English fluent, Norwegian nice to have
  • Ability to priorities tasks effectively while working on multiple projects simultaneously, ensuring accuracy and meeting deadlines.
  • Ability to act independently and to take initiative as well as ability to work within a team. Selfstarter, able to work with a high degree of independence.
GE Healthcare is an Equal Opportunity Employer where inclusion matters.

Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.


Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.

Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.


#LI-On-site

#LI-Hybrid

Additional Information:


Relocation Assistance Provided:
No
More jobs from GE HEALTHCARE
See all jobs of GE HEALTHCARE