Drug Safety Physician
Drug Safety Physician
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Job Purpose:
- Provide medical review analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
- Signal detection/analysis/evaluation and ongoing safety surveillance activities
- Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety
- Function as pharmacovigilance representative/safety scientist
General
- Maintaining a good working knowledge of the Adverse event profile of assigned products labeling documents data handling conventions clients guidelines and procedures and international drug safety regulations
- Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
- Maintaining excellent knowledge of the safety profile of assigned products
- Communicating and discussing issues related to review process with Project Manager
- Interacting with internal and external contacts for resolving issues
- Maintaining a good working knowledge of relevant regulatory guidelines
- Attend and present client/cross functional meetings along with other stakeholders
Case report Medical review
- Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client as required
- Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
- Assessing seriousness and expectedness of reported events
- Providing medical advice to case processing team
Skills:
- Excellent interpersonal verbal and written communication skills
- Computer proficiency an ability to work with web-based applications and familiarity with the Windows operating system
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learnings
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential
- Willingness to work in a matrix environment and to value the importance of teamwork
- Strong knowledge of international drug regulation including GCP GVP
Knowledge and Experience:
Good knowledge of medical terminology.
Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred.
Education:
MBBS/MD
Employment Type
Full-Time
