Medical Reviewer Device

Job Code # 395

Job Location-  Mumbai

Salary- 9 LPA to 15 LPA

Key skills-
a) 4+ years of Experience of handling clinical trial/ safety data
b) Practical experience within clinical or medical device safety setting
c) Any Graduate

Job Description-
Must have:

Bachelor/ Master degree or equivalent in Life sciences/ Alternative Medicine
Experience of handling clinical trial/ safety data – > 4 years

Responsibilities:
• Accountable for Medical Review sponsor assessments in the clinical database, including:
➢ Assess Device Deficiencies (DD) for potential to cause or contribute to an Adverse Event (AE) (Seriousness).
➢ Assess Causality for all Adverse Events (rationale may need to be provided to justify).
➢ Assess Seriousness and upgrade the case from Non-Serious to Serious if required.
➢ Complete Assessments within business timelines.
• Accountable for the medical review of relevant clinical, other solicited and spontaneous
cases (including literature articles), medical assessment (including seriousness,
labelling and causality along with the company causality statement as well as IMDRF
Annex E and F codes) and overall cohesiveness of safety reports for a particular product
or group of products on a national, regional, or global basis in line with regulatory and
SOP requirements.
• Accountable for correct identification of potential serious public health threats and
events requiring escalation for safety issues from safety reports.
• Accountable for the final medical review of Safety Reports including performing tasks
such as communication with the appropriate Clinical Safety Personnel and where
appropriate with the Clinical Science Group ensuring that all necessary queries have
been addressed.
• Accountable for confirming that the correct strategy has been taken for the analysis of similar incidents/events (e.g. selection of IMDRF codes for search basis) for medical devices.
• Responsible for generating, sending and tracking medically relevant queries.
• Developing and maintaining thorough knowledge of the appropriate disease biology areas & important safety concerns for marketed medical devices as well medical devices in development for which the Medical Reviewer (Device) is responsible

• Collaborate with the Clinical Safety group to be up to date with all the safety information required to complete a robust medical review of Safety Reports and assessment of company causality.
• Working in collaboration with Sponsor when needed to ensure a timely response to relevant safety queries from other company stakeholders and indirectly from regulatory authorities, particularly those associated with MDV reportable incidents/events.
• Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive workflow management.

Required Experience and/Competencies Required:

• Knowledge of medical device risk classification
• Practical experience within clinical or medical device safety setting
• Good knowledge of and interest in MDV practices
• Ability to evaluate and interpret scientific data
• Good knowledge of US and EU medical device vigilance regulatory requirements (e.g. MDR)
• Excellent written and verbal communication skills and ability to present and critically
discuss MDV data in both internal and external discussions