Our client is a leading pharmaceutical company that specializes in dermatological treatments with a mission to advance dermatology through innovation and manufacturing. They are looking for a Pharmacovigilance & Medical Information Associate in the GTA.
The successful candidate would be a member of the Pharmacovigilance department, and report to the Pharmacovigilance & Medical Information Manager.
- Contributes to daily Pharmacovigilance and Medical Information operations for medicinal products, medical devices, biologics and cosmetics, including case management of adverse event records (triage, coding, analysis), assessment of incoming communication to identify potential adverse event reports and submission of expedited and periodic reports to Health Canada.
- Manages Medical Enquiries in a timely manner, including maintenance of standard response documents in collaboration with Medical Affairs.
- Manages incoming communication for potential adverse event reports and external queries via local intake system, phone, fax, mail, digital sources and other methods.
- Management of Pharmacovigilance & Medical Information activities, under the supervision of the PV&MI Manager.
- Organizes reconciliations with other functions and organizations (e.g. products quality complaints, corporate PV, Market research, licensed partners).
- Participates to periodic Corporate PV meetings, if any.
- Provides responses to internal and external customers in a timely manner.
- Contributes to the maintenance of the local Pharmacovigilance system including quality documentation and related indicators, audits and inspection readiness as well as the filing and archiving of relevant documentation.
- Contributes to review and assessment of programs and processes to meet regulatory reporting requirements.
- Acts as a deputy Local Safety Officer.
- Assists with maintenance of the Quality System for Pharmacovigilance and Medical Information and local compliance.
- Provides training to new employees and license partners / vendors (including local Market Research agencies) about adverse event collection and Reporting; organizes regular refresher training to employees.
- Contributes to Pharmacovigilance inspection readiness, and supports and CAPA plans, and local audit/inspection efforts.
- Maintains a working knowledge of company policies and procedures, departmental processes and associated work instructions, evolving local and international regulations, guidelines and applicable directives, company products, and skin anatomy and skin common diseases.
- Applicable healthcare education/certifications (i.e. RN, LVN, pharmacist) fulfilling the Healthcare Professional requirement.
- 2+ years of relevant PV&MI work experience, in a pharmaceutical company or clinical trials.
- Working knowledge of Health Canada guidelines for post-marketing drugs, cosmetics and medical device safety surveillance.
- Working knowledge of medical terminology, medical conditions, chemical structures/biological systems and drug products.
- Familiar with relevant computer software such as Oracle Argus or similar Drug Safety database.
- Able to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- Able to apply concepts such as fractions, percentages, ratios, and proportions to practical situation.
- Able to define problems, collect data, establish facts, and draw valid conclusions.
- Able to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Bilingual – English/French
To apply, please submit your resume using the Apply Now button.
We thank all interested applicants, however, only the candidates chosen for an interview will be contacted.