Pharmacovigilance Associate - Greater Toronto Area

Rossi Recruitment; Mississauga; On-site; CAD 60,000 - 80,000; Full time

Job summary

A generic pharmaceutical company is seeking a Pharmacovigilance Associate to process safety data, compile PSURs, and perform signal detection. Candidates should hold a Bachelor's degree with 3 years of relevant experience, including 2 years in Pharmacovigilance. Strong organizational, written, and verbal skills in English are required. This role is vital in ensuring compliance with regulations and effective data management.

Qualifications

• 3 years relevant work experience, including 2 years in Pharmacovigilance.
• In-depth knowledge of global and local regulatory requirements.
• Proven ability to multi-task and meet deadlines.

Responsibilities

• Process Safety data according to regulations and guidelines.
• Compile PSURs and submit to Health Canada.
• Perform signal detection and update product monographs.

Skills

Excellent written and verbal skills in English

Excellent organizational skills

Attention to detail

Proven ability to work independently

Ability to manage competing priorities

Education

Bachelor's Degree in Scientific, Healthcare or Life Science discipline

Job description

An exciting and agile generic pharmaceutical company is excited to announce an opening for a Pharmacovigilance Associate position in the GTA.

Responsibilities

• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and product requirements.
• Detailed knowledge of the following guidance documents :
• Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102);
• Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063);
• The Marketed Health Products Directorate (MHPD) guidance documents :
• Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry
• Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry
• Perform Pharmacovigilance activities for all marketed drug products and API molecule level including but not limited to, collecting, and tracking incoming Adverse Drug Reactions, medical inquiries and end point follow up information. Prepare line listing for all the ADRs received.
• Keep records for nullifying ADRs with justifications.
• Compile ADRs, Completed CIOMS and submit to Health Canada as per the guidance.
• Perform literature searches, write narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations. Creating, maintaining, and tracking cases as applicable.
• Liaise with Regulatory Affairs department for tracking requirements and electronic reporting if required.
• Compile PSURs for all drug products within the timeline required by Health Canada Guidance.
• Perform signal detection and update product monograph as required.
• Ensure to meet quality, productivity, and delivery standards per project requirements.
• Ensure compliance to all marketed product related processes and activities.
• Maintain Pharmacovigilance agreement with all the vendors as required by Health Canada.
• Set up and maintain project files, standard templates, electronic forms, databases, and workflow as per project requirement.
• Record keeping.
• 100% compliance towards all people practices and processes and record keeping.

Requirements

• Bachelor's Degree in Scientific, Healthcare or Life Science discipline with at least 3 years of relevant work experience, inclusive of up to 2 years of Pharmacovigilance experience.
• Excellent written and verbal skills in English
• In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements
• Excellent organizational skills, time management skills, attention to detail and accuracy.
• Proven ability to work independently and autonomously with policies and practices
• Proven ability to multi-task, meet strict deadlines, manage competing priorities
• Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities