Senior Associate PV (ICSR)

Advity Research; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

A leading pharmaceutical research firm is in search of a professional with 3-4 years of pharmacovigilance experience. The role involves managing case processing of drugs and devices, conducting quality control reviews, and ensuring compliance with regulatory requirements. The ideal candidate will possess extensive medical terminology knowledge and excellent communication skills in English. This position offers the opportunity to work closely with global teams on critical safety processes.

Qualifications

• Minimum of 3-4 years of experience in pharmacovigilance including ICSR.
• Extensive knowledge of medical terminology and clinical pharmacology.
• Excellent communication skills in professional English.
• Sound knowledge of pharmacovigilance principles and international regulations.

Responsibilities

• Manage case processing for drugs, devices, vaccines, and cosmetics.
• Conduct QC review of literature searches and ICSR activities.
• Report IC.S.Rs and submit deliverables to clients.
• Maintain ICSR and related trackers.
• Provide queries for additional information needed in IC.S.Rs.

Job description

Qualifications

• Minimum of 3-4 years of experience in pharmacovigilance including ICSR (from literature sources) and aggregate reports.
• Extensive knowledge of medical terminology, clinical pharmacology, patent treatment, diagnostic investigations and pathology.
• Sound knowledge of pharmacovigilance principles and international regulatory requirements related to drug and patient safety.
• Possess excellent communications skills with professional English speaking, writing, presenting skills and must be detailed oriented.
• Excellent organizational and time management skills.
• Ability to work effectively independently and within a team environment and across global teams.

Detailed Responsibilities

• Case processing (solicited and unsolicited reports) for drugs, devices, vaccines, biologic product and cosmetics.
• QC review of Literature search and Individual Case Safety Reports (ICSRs) activities.
• Reporting IC.S.Rs and submission of all PV, CT deliverables to client/Regulatory authorities.
• Maintenance of ICSR, Literature search and other related trackers.
• Perform periodic and regular reconciliation with clients.
• Provide queries relating to additional information required for processing IC.S.Rs and share to MICC team to perform follow up activities with HCP/Customer/Patients.
• Preparation or support preparation of safety processes and procedures (SOPs/Work instructions).
• Perform reconciliation with clients.
• Monitoring Health authority websites for latest updates.
• Training other Pharmacovigilance team associates on relevant company procedures, latest Regulations and Guidelines.
• Compliance with related SOP/procedures on quality and timely submission of PV deliverables.
• Compliance with Pharmacovigilance Regulations and Guidelines.