Principal Pharmacovigilance Associate

Purpose of Pharmacovigilance Associate Role:

The purpose of the Pharmacovigilance Associate role is to monitor and manage the safety aspects of clinical studies/post-marketing surveillance including but not limited to monitoring safety mailbox, preparation of safety management plan, setting up safety database for studies, processing & submission of ICSRs (SAE/SUSAR/AEs) in accordance with ICH-GCP, SOPs and applicable regulatory requirements/ensure compliance with regulations.

Major Responsibilities:

Describe the tasks, duties, and responsibilities the employee who is working on this role is supposed to carry out. List the responsibilities in the order of their importance.

Pharmacovigilance Associate

• Manage project-specific activities which may include:
• Preparation of safety management plan, preparing safety DB configuration documents for each project; preparing slides for project kick off meetings.
• Case processing activities and drafting safety narratives, monitoring of safety mailbox, filing study documents in TMF.
• Manages unblinding procedures.
• Conducting literature searches and monitor for adverse event reports as well as monitor post approval commitments.
• Participate in clinical study reconciliation activities, as requested by client.
• Liaison with medical monitors/drug safety physicians, clients, and study teams as appropriate to clarify information required for case processing.
• Participation in inspection/audit related activities; Assistance in preparation or implementation of corrective/preventative actions relating to case processing.
• Timely submission of reports to regulatory agencies in accordance with applicable regulations and tracking the details of submissions for compliance.
• Provision of on-the-job training and mentoring of junior staff.

Qualifications & Experience:

State the education qualifications required along with the desired experience level. Mention specific skills and certifications which the candidate should have to apply for the role.

Education

• Registered nurse/pharmacist or with health/biomedical degree or other related scientific degree/qualification is required.
• Postgraduate qualifications or certification in clinical trials will be an advantage.

Knowledge, Skills, and Abilities (Pharmacovigilance Associate)

• Knowledge of clinical trials and pharmacovigilance requirements. Knowledge/experience in international drug safety-regulatory reporting obligations and compliance.
• Experience in coding medical terminologies, case processing, safety report submission is preferred.
• Thorough knowledge of medical terminology and ability to summarise medical information is required.
• Strong computer proficiency and ability to work in specific databases is required/preferred.
• Ability to follow guidelines and procedural documents is required. Experience of working with SOPs etc. is required.
• Fluent in both written and oral English.
• Good interpersonal skill to professionally communicate with all levels of the organizations.
• Good time management & multi-task capability.

Experiences

• 2 years to 4 years of pharmaceutical/CRO experience with focus on safety related areas in clinical trial is required.