Org. Unit Descriptor:
Global Pharmacovigilance (PV) is an operating department within the AGO-Scientific and Regulatory Affairs. The PV department is involved in the processing and submission of adverse drug reaction reports and safety data management to support the development and commercialization of Apotex products in the markets in which we do business, in compliance with PV regulations & relevant ICH guidelines.
Job Summary: Performs global Pharmacovigilance processes of the unit: Quality Management Review and compliance tracking; Clinical trial serious adverse event (SAE) reconciliation and occasional case processing; Spontaneous adverse drug reaction reporting and case processing; literature review; drafting Periodic Safety Update report; Risk Management plans on products developed and manufactured by Apotex and Risk Management program support. Interacts with health professionals and consumers and affiliate offices during investigation of all case reports. Prepares and submits expedited case reports and periodic safety update (PSUR) reports in compliance with drug safety regulations and ICH Guidelines. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities relating to Risk Management programs and pharmacovigilance. Provides after-hour coverage of PV responsibilities as required.
Performs routine PV functions as required
Monitors E2B compliance and validates electronic safety data capture for all markets
Performs systematic check on data integrity of departmental databases (AERS, OC)
May assist in the preparation of line-listings, Safety reports & Risk Management plans when required.
Process all relevant forms and paperwork involved in maintaining patients in Risk Management programs.
Ensure company compliance with regulatory guidelines pertaining to Risk Management Programs and PV Systems; identifying process improvements and escalating opportunities to supervisor.
Respond in a timely manner to requests from business partners or other registries in compliance to regulatory timelines.
Maintain consistent and accurate patient data electronically by way of discrepancy management and organization.
Report adverse events in accordance to PV SOPs.
Process lab data received for Risk Management programs, including entry into relevant database and QC.
Respond to queries from clients (including internal and external to Apotex Inc.) in a timely manner.
Tracks compliance of internal PV processes, external service providers and business partners involved in the safety data exchange process. Prepares monthly or quarterly reconciliations reports as required.
Prepares and monitors Company Core Safety Profiles and enters core event data into safety database (AERs)
Assist in the maintenance of unit SODs, Safety Data Exchange agreements with business partners and internal work instructions.
Maintain departmental document management, including filing and scanning of source documents.
Performs all other duties, special projects and after-hour coverage of the PV unit as assigned.
Escalates to Project leader, calls and requests for Health Care Professional consultation involving patient risk management.
Develop process improvement initiatives in consultation with management. Technology/Instrumentation (type & complexity):
Maintains user-level knowledge of IRMS, Oracle AERS and Oracle Clinical safety databases and MedDRA terminology.
Relationship with Internal/External Customers & Stakeholders:
Communicates with external customers, pharmacists and physicians to investigate and follow-up on ADR reports during clinical trials, post-marketing and in the literature.
Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data.
Develops strong relationships with external partners, CROs, international Apotex affiliates and clients (internal and external), demonstrating corporate values in the performance of work and in all interactions with others.
Interact with Sales and other internal departments when necessary. Problem Solving Analysis:
Prepares responses to slightly more complex queries, and requests for safety information from internal customer (RA, QA, NPD project teams etc.).
Resolves GPV unit and risk management program issues with internal customers and team members and participates in resolution of issues with external service providers and business partners.
Contributes to interpretation of PV regulations and applies sound decisions related to regulatory guidelines and policies.
Leadership/Professional Development of Self & Others:
Shows initiative to remain current on new PV regulations and international guidelines and seeks guidance from Project Leaders and management to enhance knowledge.
Compliance and Due Diligence:
Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant Pharmacovigilance regulations.
B.Sc, MSc. In related Health Science discipline
Minimum 2 years pharmaceutical experience preferably in a clinical, regulatory or Pharmacovigilance role
Excellent technical & research skills
Excellent oral/written communication in English; bilingual preferred
Advanced knowledge of Microsoft office: Excel, Powerpoint, Word
Knowledge of Oracle AERS, Oracle Clinical, MedDRA, Crystal Reports and online literature searching preferred
Excellent organizational & interpersonal skills; experience in working in a dynamic team environment
Knowledge of GMP, GCP, relevant PV regulations and ICH guidelines on safety data management in clinical trials and post-approval.
This position is located at our Signet site at Weston Road and Steeles*