Pharmacovigilance Associate Jobs

Job Title: Pharmacovigilance Associate

Reports to: Manager, Pharmacovigilance

Job Location: Oakville, Ontario

SCOPE OF THE POSITION

The Pharmacovigilance (PV) Associate is primarily responsible for collecting, assessing, evaluation and reporting of adverse reactions of Sterimax post market products.

KEY RESPONSIBILITIES

• Serve as pharmacovigilance resource during inspections and audits
• Serves as pharmacovigilance liaison and resource to internal and external groups on issues related to pharmacovigilance
• Prepare and submission of aggregate reports including PBRERs, as needed
• Identify missing or discrepant information and perform active case follow-up via verbal or written contact
• Receive, triage and process adverse event reports from all sources including post-marketing and published literature
• Supports and prepares risk management plans (RMP) and interacts with PV vendors and Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies
• Prepare expedited reports for submission to regulatory authorities
• Perform data entry and quality review of adverse event reports into the adverse event database, including accurate coding of MedDRA terms and preparation of case narratives
• Contributes to the development, management, and generation of SOPs for pharmacovigilance and drug safety monitoring. Evaluates and identifies areas that may require improvement or clarification and drafts procedural changes and adaptations as needed. Develops and implements internal pharmacovigilance guidelines, processes
• Perform assessment of seriousness, expectedness, causality, and reportability in accordance with guidelines

Other duties as assigned.

EDUCATION AND EXPERIENCE

· Bachelor’s Degree in science (Pharmacology, Chemistry, Biology or Life sciences) or equivalent education/training

· Experience working in a pharmaceutical quality systems environment (i.e. deviations, CAPA, Change Control, SOP’s etc.)

· Experience with of Good Documentation Practices and Canadian GMP’s and Quality Systems

SKILLS/COMPETENCIES

· Demonstrated organizational, problem solving, research and analytical skills, with a strong attention to detail.

· Flexible and able to manage and prioritize multiple projects in a fast-paced environment.

· Demonstrated willingness to take initiative and become directly involved in planning, problem solving, and execution of work in a team environment.

· Highly motivated. Interest in expanding knowledge and growth within the organization.

· Ability to contribute to a positive and productive work environment through effective collaboration with cross functional organizations.

· Effectively communicates in English (oral and written)

SteriMax is an equal opportunity employer that is committed to fair and accessible employment practices for all existing staff and potential candidates. Please advise Human Resources if you require an accommodation to participate in the recruitment process.

AGENCY NOTICE: Please note that SteriMax does not accept unsolicited resumes from recruiters or employment agencies unless we invite in writing selected recruitment agencies to participate in specifically named recruitment projects. SteriMax will not consider any referrals or agree to payment of referral or recruitment fees. In the event, a recruiter or an agency submits a resume or candidate without a previously signed agreement and a written invitation, SteriMax explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.