Scientist, Pharmacovigilance

Job Title

Medical Review of ICSR's

Job Description

This role performs Medical Review of ICSR's which include: Independent submissions to the FDA and increased responsibility of adverse event reporting including quality control and medical analysis for both brand and generic products. Medical Review involves a thorough review of each case utilizing advanced clinical interpretation of the case data to draw a causal relationship and the formulation of an accurate and complete medical opinion. Medical Reviews of ICSR's include post marketing products and investigational compounds. This position is responsible for providing oversight to vendors for data entry and processing activities. This can include but is not limited to writing medical opinions, submission to the Regulatory Authorities, conducting quality checks on vendor PV activities. This position ensures consistent and timely reporting of all Adverse events received by Amneal to the Regulatory Authorities, maintaining knowledge of and implementation of Pharmacovigilance best practices as well as regulatory guidances. This position is expected to contribute to the drafting and maintenance of SOPs related to Pharmacovigilance activities.

Essential Functions

• Medical review of Investigational New Drug (IND) Serious Adverse Events Medical review of post marketing adverse event reports for spontaneous, medical literature cases for brand and generic products including case closure. Review and submission of expedited ICSR's to relevant Regulatory Authorities.
• Review and provide oversight for all vendor activities performed in relation to ICSR's: case entry and assessment of listedness and seriousness, quality check and creation of AE medical narrative, interpret and code AE's, medical conditions, medications, laboratory results and procedures using MedDra Dictionary.
• Collaborate with regulatory and PV Operations departments for AE data gathering, AE reconciliation and AE initiation. Track and maintain timely closure and submission of AE's according to relevant Regulatory Authority regulations. Audit participation when required with Regulatory Authorities.
• Safety label review and safety label update review for marketed products.
• Review of signal detection data and ADR summary every 6 months for each product.
• Conduct medical literature review for all Amneal products for special projects. Perform oversight and analysis of literature review conducted by GPS vendor.

Additional Responsibilities

• Medical Affairs: Team lead for medical affairs sub-groups for MIRF (Medical Information Request Forms): Information request from HCP's which are submitted by IMPAX sales reps and MSLs and these requests are managed by medical affairs using SRL's and escalated to MSL's if required.
• Medical Affairs: Team lead for medical affairs sub-groups for SERC (Scientific Evaluation and Review Committee): Creating and updating standard response letters, scientific product data, FAQ's, etc. for use by medical affairs and the drug safety call center. Also reviews slide decks and materials used by field based Medical-Science Liaisons (MSL's).
• Medical Affairs: A designated representative from the Medical Safety Science Department with technical expertise to verify the medical and scientific integrity of the Asset or Communication and to ensure that medical and/or scientific information contained in the Asset or Communication is accurate and not misleading, medically relevant, supported by the references provided, well-substantiated by scientific data, truthful and balanced, and scientifically rigorous.

Qualifications

Education:

• Medical Doctor Degree Medical Doctor Degree Foreign medical graduates from WHO accredited schools acceptable. - Required

Experience:

• 2 years or more in Drug Safety / Pharmacovigilance

Required Skills

• Decision Making
• Detail Oriented
• ICH Guidelines
• Investigation
• Literature Reviews
• MedDRA
• Patient Safety
• Quality Management Systems
• Regulatory Compliance
• Regulatory Requirements
• Risk Analysis
• Risk Management
• Verbal Communication Skills
• Writing

Job Info

• Job Identification 8167
• Job Category Pharmacovigilance & Drug Safety
• Locations 1045 Centennial Avenue, Piscataway, NJ, 08854, US
• Job Schedule Full time