Drug Safety Physician

Posted 3 hours ago
Job purpose
To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis of similar events, company causality assessment, and expectedness assessment, review of MedDRA coding, causality assessment signal detection, risk management, and pharmacovigilance oversight for assigned projects.
Duties and responsibilities
Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to drugs.
Identifying and assessing safety risks associated with drugs, and making recommendations for managing or mitigating those risks.
Communicating safety information to regulatory agencies, healthcare professionals, and the general public.
Collaborating with other members of the drug development team, including pharmacologists, toxicologists, and statisticians, to ensure that safety issues are adequately addressed.
Participating in the development of risk management plans, which outline strategies for minimizing the risk of adverse events associated with drugs.
Reviewing and approving of protocol for clinical trial safety and contributing to the report of clinical trial safety.
Staying up-to-date with the latest developments in drug safety, including new regulations and guidelines, to ensure that safety evaluations are conducted in accordance with the latest standards.
Participating in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately.
Collaborating with other departments within the company, such as research and development, regulatory affairs, and marketing, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders.
Contributing to the preparation of regulatory submissions and responding to questions from regulatory agencies regarding the safety and efficacy of drugs.
Providing medical expertise and guidance to other members of the company, such as sales and marketing teams, to ensure that the appropriate safety information is communicated to healthcare professionals and patients.
Participating in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market.
Being responsible for the overall safety of the drug, from preclinical development to post-approval.
Education & Experience
Bachelor’s or Master’s degree in Medical or Dental Sciences
Previous experience that provides the knowledge, skills, and abilities to perform the job (3+ years’).
Experience working in the pharmaceutical/CRO industry preferred
Knowledge, Skills and Abilities
Excellent technical data interpretation skills
Strong understanding of Medical Sciences
Excellent interpersonal skills including problem solving
Strong negotiation skills
Excellent oral and written communication skills with strong presentation skills
Significant knowledge of global, regional, national and other document development guidelines
In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
Great judgment and decision-making skills
Ability and desire to work in a team-oriented environment.
Excellent written and verbal communication skills
Highly proficient with Microsoft Word, PowerPoint and Excel.
Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
Possesses a collaborative, results-driven style.
Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time - the incumbent may be required to working slots catering to different time zones