Pharmacovigilance Auditor Jobs

Play an integral role in the management of daily operational activities of the Global Submissions Team within Case processing.

Collaborate with Regulatory Intelligence team, Safety Data Management to maintain accurate reporting rules in the Safety Database.

Identifying root cause for late ICSR submissions and to provide appropriate corrective and preventive actions to Compliance and Business Management team.

Responsible for timely submission of expedited ICSR reports to Ethics Committees and Investigators based on the country requirements.

Involved in preparing safety ICSR submission package to Health Authorities as per the requirements.

As Submissions SME, support local safety managers on daily basis for all ICSR submission related matters.

Ensure the smooth operation of Coordinator and Associate case management activities to maintain compliance with corporate and Canadian regulatory reporting requirements

Assess needs, optimize, and ensure maintenance of the PV Coordinators and Associates procedures according to corporate and Canadian requirements

Monitor Coordinator and Associate workload and oversee assignment of tasks to ensure compliance with corporate and Canadian requirements

Participate in the maintenance of the PV paper and electronic filing and archiving system according to corporate and Canadian requirements

Support reconciliations of the company's third-party vendor programs and licensed partners as per corporate requirements and monitor key performance indicators

Bachelor’s degree in life sciences, HCP degree preferred, or equivalent 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

· 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.

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

To manage GVP regulatory authority inspections, including hosting the inspection, preparation of inspection responses, CAPA tracking and follow-up

To manage internal and external audits on a global basis

3 years of experience in Pharmacovigilance area, data review activities including analysis of safety data

Excellent interpersonal relations, planning and organising skills

Responsabilities include, but are not limited to

To work towards timelines, company and personal objectives set by Clients and PV procedures