Senior Manager, Head of Patient Safety,saudi Arabia - Riyadh, المملكة العربية السعودية - Bristol Myers Squibb

وصف

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Position Summary

• Holds primary responsibility for all country pharmacovigilance/patient safety activities and may provide oversight for other markets. Accountability of International Patient Safety Core Activities for the Local Market remains with the HoCP appointed for the country, regardless of reporting line.
• Acts as the point person with the Health Authority on safety related matters.
• Leads and brings to resolution with all appropriate functional groups, locally and globally, all product safety related issues that arise in the country.
• Where applicable, leads and manages all local Patient Safety staff and ensures that they are competent, trained and developed, effectively to perform their roles.
• Ensures audit readiness and leads crossfunctional teams to ensure that internal and external inspections are conducted effectively.
• Acts as the local Patient Safety representative on the crisis management team, where appropriate.

Position Responsibilities

• Risk management plans
• Provision of safety information
• Implementation of pharmacovigilance Audit and Inspection Readiness
• Planning, processing and reporting of Aggregate Reports to HA and EC (as required)
• Maintenance of pharmacovigilance Awareness and Training
• Implementation of Pharmacovigilance Agreements
• Collection, followup and forwarding of spontaneous, literature, solicited, post

- marketing AE cases

• Submission of single cases to local Health Agencies(HA) and Ethics Committees (as required)
• Local Market Safety Data Quality

Qualifications

• University Degree in Pharmacy ( Holding Valid Saudi Health specialties license)
• At least 5 years in the Pharmaceutical Industry, usually with at least 3 years' experience working in Pharmacovigilance or in a closely aligned field (e.g. Regulatory, Clinical, or Medical Information) within the pharmaceutical industry, medical or Regulatory environment preferably in the respective country.
• Fluent in Arabic and English, both speaking and writing.
• Due to the obligatory requirements from the Saudi FDA, Saudi Nationals

Key Competency Requirements

• Demonstrated strong, effective organizational, facilitation, interpersonal and communicating skills with crossfunctional teams locally and within Worldwide Patient Safety to achieved desired outcomes. Develops excellent working relationship with the local HA or country HA liaison group/body where such opportunities exist. Positively contributes to the shaping of pharmacovigilance/patient safety within the local market through interactions with the HA and relevant professional associations.
• Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding safety risk related requirements internally (local/regional/HQ) and externally (HAs, BPs).
• Subject matter expert in local, regional and any other relevant legislation with regard to pharmacovigilance (e.g. ICH, CIOMS), as well as BMS Patient Safety related process and systems. Clearly articulates implications of changes. Contributes actively to the implementation of new legislation and Worldwide Patient Safety procedures/systems. Monitors and ensures adherence to local/regional/global regulatory requirements and relevant Worldwide Patient Safety procedures.
• Recognised as safety expert within market/region and is the goto person for any safety related issues in country. Leads crossfunctional teams for Risk Management and other safety related matters.
• Utilizes effective decisionmaking and a problemsolving approach to address safety issues, in a timely manner, while balancing the operation and strategic needs. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated safety issues, while retaining accountability.
• Ensures pharmacovigilance compliance (and thus inspection readiness) with relevant internal and external process/guidelines/regulations. Ensures appropriate management of Local Market Patient Safety Core Activities (AE reporting, aggregate report submission, training, audits/inspections, Risk Management processes and safety issues). Ensures high quality safety documentation. Provides support to Patient Safety staff.
• Ability to manage multiple tasks and utilize effective problemsolving app