Manager, Patient Safety - Montréal, Canada - Sandoz

Sandoz

Verified Company

Montréal, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

#1 in the Canadian Generic & Biosimilar drug market is what Sandoz Canada is aiming for Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic.

And we never stop asking:
how can we continue to pioneer access in an ever-more digital and global world? As the Manager, Patient Safety you will:

Drive pharmacovigilance strategy and operational excellence for all marketed and investigational products
drugs, biologics (biosimilars) and medical devices
distributed / commercialized by Sandoz in Canada.
Ensure the oversight and quality management of the Pharmacovigilance System and Procedures, in collaboration with the 3rd party vendor, local leadership, and local Quality Assurance (QA) function.
Oversight of Pharmacovigilance aspects of Patient Oriented Programs (POP) in collaboration with other relevant teams within Sandoz Canada.

Your responsibilities will include, but are not limited to:

Single point of contact to Health Canada on Pharmacovigilance aspects: As defined by Canadian regulations, you will act as the single point of contact with the Local Health Authority concerning Pharmaco-device vigilance matters.
Act as the Country Patient Safety Head (CPSH) for Sandoz Canada. You will be a member of the local Scientific Affairs leadership team to assure we are meeting its regulatory obligations to the local health authority. The role also requires stakeholder management at a senior level within the local Sandoz organization and with your global counterparts at Sandoz Global Patient Safety.
Management of Safety Information:

Ensure oversight of the 3rd party Vendor, structure and performance, covering the following aspects: - Local Procedures - Development, implementation, and management of Risk - Management Plans - Case Processing (triage/ documentation; translation; data-entry; follow-up activities and archive, as applicable) - ICSR reporting and aggregate reporting (PSUR, DSUR, ASR) - Training of Sandoz Canada personnel in relation to PV - Management of PV aspects of local licensing agreements - Management of PV aspects of local Patient Oriented Programs (POPs), Social Media Listening and Digital Engagement Assets Initiatives - Pre
- and post-authorization safety studies, with appropriate PS input as required

Documentation: Ensure access to all information sources maintained to oversee structure and performance of the PV system 3rd party vendor at local level.
Monitoring internal and external compliance of

Safety Reports:
Monitor internal and external compliance (regulatory reporting) according to defined timelines.

Ensure that delayed safety cases or aggregate reports are properly captured by 3rd party vendor, investigated and root causes addressed through any corresponding corrective/preventative action.

Notification and escalation of any late case/submission to 3rd party vendor, QPPV, Director Patient Safety HUB

Oversight of local PV third parties working on behalf of Sandoz: Monitor and assess the performance and productivity of PV 3rd parties in line with the applicable regulations, agreements, and standard operational/ working procedures in place. In collaboration with QA and Vendor Management functions, ensure corrective and/or preventive actions are implemented in case contractual commitments are not met, as applicable.
Health Authority Requests: In collaboration with 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities; ensure regional alignment with defined process and QPPV office in all safetyrelated responses, as applicable.
Audits and Inspections: In cooperation with the 3rd party vendor and QA, manage any local Pharmacovigilance inspection and/or Pharmacodevice vigilance audit. Proactively cooperate in the implementation of any corrective/ preventative action as determined by auditors/ inspectors. Contribute as Pharmacodevice vigilance SME, in other internal Sandoz audits and/or thirdparty audits, as applicable.
Risk Management Plans: Ensure the country oversight of implementation of additional Risk Minimization Measures at local level, in line with Sandoz procedures and applicable regulations/ standards/ guidelines.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

What you'll bring to the role:
Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent, with a minimum of 5 years' experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
Bilingualism, English and French
Expert knowledge of Canadian require