PV Safety Specialist

IQVIA•Mississauga, ON

2d•CA$80,000 - CA$106,600•Remote

About The Position

The PV (Pharmacovigilance) Manager ensures that the collection, reporting, and management of safety information related to the clients products are organized and conducted in compliance with the clients global requirements and local regulatory requirements. As the Deputy Local Pharmacovigilance Officer (LPV), she supports the LPV in maintaining oversight of safety risk management and all other pharmacovigilance activities, ensuring pharmacovigilance compliance and inspection readiness across all affiliate functions.

Requirements

Must reside in the same country/sales region where the job is located.
Manage pharmacovigilance (PV) cases from all sources in accordance with internal procedures.
Update the Pharmacovigilance System Master File (PSMF), where applicable, in accordance with local regulatory requirements.
Conduct reviews of local medical literature and process identified cases into Individual Case Safety Reports (ICSRs) in accordance with internal procedures.
Ensure oversight and periodic reconciliation of interfaces that may represent potential sources of pharmacovigilance cases.
Ensure that appropriate safety reporting processes are in place at the affiliate level and, where applicable, documented in relevant local procedures for global and local interventional and non-interventional studies, as well as Compassionate Use Programs, in compliance with global processes and local regulatory requirements.
Provide safety information to global teams for the preparation of periodic reports, when required.
Maintain the periodic reporting tracking system, including evidence of submissions and compliance indicators.
Ensure submission of periodic reports, where applicable, to local regulatory authorities in accordance with global processes and local authority requirements.
Oversee implementation of Risk Management Plans (RMPs) in collaboration with relevant teams, in accordance with Global Safety guidance and local regulatory requirements.
Monitor local distribution of additional Risk Minimization Measures (RMMs) and related compliance metrics.
Conduct local signal detection activities and notify Global Safety of any potential local safety signals identified during routine pharmacovigilance activities.
Oversee review of signal assessment reports published by Global Safety on the WRA portal.
Ensure management of safety-related inquiries, significant safety issues, and, where applicable, local/global crisis management in compliance with global processes and local regulatory requirements.
Maintain oversight of safety communications directed to healthcare professionals or consumers, where applicable.
Provide the EU QPPV Office (Qualified Person Responsible for Pharmacovigilance) with all relevant information necessary for oversight and follow-up of requests, where applicable.
Remain informed of local regulatory requirements.
Ensure consideration of and contribute, where applicable, to local safety labeling updates in collaboration with local Regulatory Affairs.
Contribute to the implementation of regulatory commitments when applicable.
Establish and maintain a local pharmacovigilance quality system in accordance with global processes and local regulatory authority requirements.
Be responsible for training and awareness of relevant affiliate personnel and, where applicable, business partners or service providers, while maintaining compliance metrics for local training requirements.
Participate in the initiation, negotiation, drafting, implementation, and updating of local pharmacovigilance agreements with local partners or service providers.
Inform the Global Safety International Unit in advance of any locally established contract involving pharmacovigilance activities and/or impacting pharmacovigilance activities (including outsourcing arrangements with partner companies).
Ensure compliance with these agreements.
Provide timely feedback to the Global Safety International Unit regarding any changes known to the LPV (for example, changes to products covered under a pharmacovigilance agreement).
Ensure continuity of local pharmacovigilance activities, including establishing an out-of-hours coverage system.
Continuously monitor changes in local legislation, conduct impact assessments, and inform Global Safety of any relevant changes.
Ensure pharmacovigilance documents are archived in compliance with local regulatory requirements and applicable data protection regulations.
Notify Global Safety immediately upon receipt of an audit notification from a business partner or an inspection notice, and serve as the local point of contact.
Ensure implementation of CAPA (Corrective and Preventive Action) plans within established timelines.
Supervise the local pharmacovigilance team and promote pharmacovigilance standards throughout the organization.
Ensure that pharmacovigilance activities are adequately resourced.

Responsibilities

Coordinate and organize, at the national level and in collaboration with Global Safety (GS), all activities related to oversight of the safety profile of the product portfolio.
Carry out routine pharmacovigilance activities and serve as the designated responsible person in the absence of the LPV.
Manage pharmacovigilance (PV) cases from all sources in accordance with internal procedures.
Update the Pharmacovigilance System Master File (PSMF), where applicable, in accordance with local regulatory requirements.
Conduct reviews of local medical literature and process identified cases into Individual Case Safety Reports (ICSRs) in accordance with internal procedures.
Ensure oversight and periodic reconciliation of interfaces that may represent potential sources of pharmacovigilance cases.
Ensure that appropriate safety reporting processes are in place at the affiliate level and, where applicable, documented in relevant local procedures for global and local interventional and non-interventional studies, as well as Compassionate Use Programs, in compliance with global processes and local regulatory requirements.
Provide safety information to global teams for the preparation of periodic reports, when required.
Maintain the periodic reporting tracking system, including evidence of submissions and compliance indicators.
Ensure submission of periodic reports, where applicable, to local regulatory authorities in accordance with global processes and local authority requirements.
Oversee implementation of Risk Management Plans (RMPs) in collaboration with relevant teams, in accordance with Global Safety guidance and local regulatory requirements.
Monitor local distribution of additional Risk Minimization Measures (RMMs) and related compliance metrics.
Conduct local signal detection activities and notify Global Safety of any potential local safety signals identified during routine pharmacovigilance activities.
Oversee review of signal assessment reports published by Global Safety on the WRA portal.
Ensure management of safety-related inquiries, significant safety issues, and, where applicable, local/global crisis management in compliance with global processes and local regulatory requirements.
Maintain oversight of safety communications directed to healthcare professionals or consumers, where applicable.
Provide the EU QPPV Office (Qualified Person Responsible for Pharmacovigilance) with all relevant information necessary for oversight and follow-up of requests, where applicable.
Remain informed of local regulatory requirements.
Ensure consideration of and contribute, where applicable, to local safety labeling updates in collaboration with local Regulatory Affairs.
Contribute to the implementation of regulatory commitments when applicable.
Establish and maintain a local pharmacovigilance quality system in accordance with global processes and local regulatory authority requirements.
Be responsible for training and awareness of relevant affiliate personnel and, where applicable, business partners or service providers, while maintaining compliance metrics for local training requirements.
Participate in the initiation, negotiation, drafting, implementation, and updating of local pharmacovigilance agreements with local partners or service providers.
Inform the Global Safety International Unit in advance of any locally established contract involving pharmacovigilance activities and/or impacting pharmacovigilance activities (including outsourcing arrangements with partner companies).
Ensure compliance with these agreements.
Provide timely feedback to the Global Safety International Unit regarding any changes known to the LPV (for example, changes to products covered under a pharmacovigilance agreement).
Ensure continuity of local pharmacovigilance activities, including establishing an out-of-hours coverage system.
Continuously monitor changes in local legislation, conduct impact assessments, and inform Global Safety of any relevant changes.
Ensure pharmacovigilance documents are archived in compliance with local regulatory requirements and applicable data protection regulations.
Notify Global Safety immediately upon receipt of an audit notification from a business partner or an inspection notice, and serve as the local point of contact.
Ensure implementation of CAPA (Corrective and Preventive Action) plans within established timelines.
Supervise the local pharmacovigilance team and promote pharmacovigilance standards throughout the organization.
Ensure that pharmacovigilance activities are adequately resourced.