The Medical Reviewer role is to perform medical case review and to provide expertise on all aspects of it with emphasis on harmonization of medical review approach. This role will interface across all levels and functional areas of GPSRM and partner with the clinical development as well as Data Management teams.
Responsibilities:
- Perform daily medical review and causality assessment of ICSRs in accurate, consistent, and timely manner to contribute to continuous signal detection and management process
- Collaborate with other pharmacovigilance colleagues to align on a harmonized approach to identifying, evaluating and communicating safety issues
- Identify topics for escalation and collaborate with safety product leads to investigate potential safety signals
- Collaborate with GPSRM Quality and Case Management teams to identify case review issues and inconsistency and work on addressing these issues under the leadership of Head of Medical Review
- Participate in process improvements for the Medical Review team
- Maintain close communication with the case processing and medical case review vendors
Skills:
- Ability to synthesize and analyze safety data from various sources.
- Proficiency in problem-solving within a highly complex environment
- Strong communications skills, both written and spoken, ideally with experience in medical / scientific writing
Requirements
Qualifications:
- Medical Degree with a minimum of 1 year of medical practice is required
- Must have a minimum of 2 years of pharmaceutical industry experience within pharmacovigilance or clinical research
- Experience in medical case review required
- Sound clinical acumen and a wide range of therapeutic area knowledge
- Expertise in international regulations governing drug safety.
- Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred
- Experience in managing compliance or audits
