Patient Safety Manager - #366599


Date: 6 days ago
City: Midrand, Gauteng
Contract type: Full time
Your Responsibilities Include, But Not Limited To

  • Leadership: Build strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director Patient Safety HUB/ Associated Director Patient Safety HUB and 3rd party vendors.
  • Communication flow: In collaboration with the Sandoz regional Hubs and the 3rd party vendor operational hubs, ensure that communication flows for safety processes including any local sources of safety data and safety issues are identified and implemented.
  • Single point of contact [and 24hr availability]: As defined by local regulations act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance in the country(ies) and act as the single point of contact with the Local Health Authority [on a 24-hour basis where required].
  • Management of Safety Information
    • Management of Adverse Events: Ensure the local management of adverse event information, with the following aspects (In collaboration with 3rd party vendor routine operational activities may be partially or completely outsourced):
      • Identification of sources of adverse event information, from any source in the country
      • Maintaining oversight on case content and reporting.
    • Product Complaints management: Maintain awareness of product complaints received in the affiliate, ensure exchange and reconciliation of product complaints associated with adverse events.
    • Management of Periodic reports: In collaboration with other local, regional and global functions, ensure the planning of periodic reports to meet local compliance obligations, maintain oversight on submission of reports authored by global functions.
    • Management of Local Literature: In collaboration with 3rd party vendor, identify the local journals required for screening, maintain overview on search results specifically any potential safety signals or aspects relating to benefit/risk.
    • Support business in the set-up of programs and any other activities that may elicit adverse event and other safety relevant information by collaborating in the set-up of programs/projects and implementation of reporting pathways, including data reconciliation and source data verification.
  • Sandoz product safety profiles and related actions
    • Health Authority Requests (and other externally generated signals): 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.
    • Awareness of Sandoz product safety profiles: Maintain oversight on results of the signal management process, including any relevant subsequent actions, such as safety variations, ARMM, or ad hoc safety measures.
    • Risk Management: Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks. Ensure the country oversight of implementation of Post Authorization Safety Studies and additional Risk Minimization Measures at local level.
    • Ad hoc Safety Measures: Ensure readiness to implement ad hoc safety measures such as emerging safety issue notification, Direct HCP or Patient communication, Urgent Safety Restrictions, Product Recall for Safety or Quality reasons
  • QMS and supporting processes
    • Local Procedures: Ensure the local Pharmacovigilance requirements are met. Identify specific requirements that may not be covered by global procedures and communicate to the Sandoz regional hub. Where required, implement local procedures to supplement PS global procedures and to ensure compliance national requirements.
    • Trainings: Ensure that all local internal and external stakeholders are adequately trained from pharmacovigilance obligations.
    • Records management: Ensure access to all records are maintained to oversee the flow of safety information at local level.
    • Compliance Management: Participate in compliance governance to monitor internal compliance for local processing and external compliance.
    • Audits and Inspections: In cooperation with the 3rd party vendor, QA and other applicable groups, maintain audit/inspection readiness with the support of regional hubs and 3rd party vendor and manage any local Pharmacovigilance audit/inspection. Contribute as Pharmacovigilance SME, in other internal Sandoz audits and/or third-party audits, as applicable.
    • Deviation and CAPA: Identify and document local deviations and proactively, cooperate in the implementation of any corrective/ preventative action as determined by root cause analysis and CAPA plans.
    • PSMF/PSSF: Where required, prepare and maintain the PSMF/PSSF, with input from global functions and 3rd party vendor
    • PV Agreements: Input, review, and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information, exchange of other safety information and implementation of safety measures.
    • Regulatory Intelligence: Drive the impact assessment of new local pharmacovigilance-related legislation.
    • BCP: Ensure that suitable local BCP plans are in place and tested to safeguard the flow of safety information in case of business disruptions.
    • Local 24hr accessibility: ensure that suitable local systems are in place that will allow concerned external stakeholders to report adverse events anytime.
  • Governance
    • Sandoz Patient Safety Governance: Collect and share relevant metrics for local business volumes and performance. Participate in governance meetings at regional and global level to have oversight on the performance of the PV system.
    • Affiliate Governance: participate or maintain awareness of key governance meetings in the affiliate to stay informed of important developments in the affiliate that may have an impact on the conduct of safety activities.
    • External governance: Build relevant external interfaces with local distributors, license partners, vendors to collaborate on day-to-day matters and oversee the adherence to safety relevant obligations of contracts and PV agreements.
    • External relationships: build relationships with health authorities, industry associations, healthcare professionals, patients and caretakers etc..
    • Notification and escalation: share any business observations with relevant stakeholders (local peers, Sandoz PV Hub, 3rd party vendor) in the context of day-to-day business relationships. If the observation cannot be addressed, or if an issue develops, formally escalate using the defined escalation procedures.
  • Projects (where applicable)
    • Participate in initiatives on local/regional/global level as SME, or champion to contribute to business improvement for PS activities.
    • Lead business improvement activities in the country, cluster or region to address specific regulatory or business situations
    • Contribute to mentoring and continuous education of PS staff on local/regional/global level
What You’ll Bring To The Role

  • Demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry.
  • Knowledge of regional and local requirements relating to PV. Ability to solve complex regulatory issues and requirements.
  • Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains. Ability to effectively communicate with different stakeholders.
  • Experience in PV audits and inspections.
  • Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
  • Experienced in a matrix organization, including ability to influence and provide guidance and direction to team members.
  • Demonstrated ability for innovative and big picture thinking.
  • Strong planning, negotiation, organizational and interpersonal skills.

Desirable Requirements

  • Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
  • Fluent in written and spoken English.
  • Fluent in written and spoken local language.
  • Minimum 2 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
  • Computer/IT systems literacy

Why consider Sandoz?

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?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz! #Sandoz
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