Pharmacovigilance Manager

Purpose of the Role

The primary role of the Regional PV Manager is to provide support within PV function in the development, and continuous improvement of the Pharmacovigilance system at NewBridge Pharmaceuticals. This includes implementation and development of a full scope of processes. and activities performed by the company, our Partners, Local Distributors and Service Providers.

The Regional PV Manager will function as the key point of contact for Pharmacovigilance for NewBridge shall act as the QPPV (Qualified Person for PharmacoVigilance), where required, for internal and external stakeholders and shall work closely with all functions, partners, service providers and local distributors.

Required Competencies, Qualifications and Experience

• Graduate, with Degree in Pharmacy or Medicine
• Preferable with Masters in Life Sciences, MBA, etc.
• Minimum of three years proven performance in a similar role and experience in a pharmacovigilance role in an MNC Pharmaceutical/healthcare company in the MENA Region

Responsibilities & Accountabilities

• Maintain the established Pharmacovigilance (PV) system for NewBridge, and act as 24/7 point of contact for all PV matters/queries from Business Partners (BPs), and responsible for:
• NewBridge Pharmaceuticals (NBP) PVAs/SDEAs, and its annexures.
• Responding to BP requests whenever required.
• Competent Authorities requests and relevant stake holder notifications (including BP/MAH).
• Main PV responsible for BPs regular meetings preparation and readiness.
• Support in PV deviations and change control requests whenever required.
• Impact analysis of RI changes on the BPs PVAs/SDEAs.
• Create, update and maintain NBP PSMF.
• Update and maintain NBP database including all trackers.
• Main 24/7 PV responsible for any Product Recalls and their periodic Mock-ups. In addition to any relevant communications with BPs and Local Distributors (LDs)/ Service Provider(SPs).
• Ensure Business continuity/recovery plan is implemented for all PV activities and ensure frequent testing of the BCP.

PV QMS:

• BP audits logistics, audit readiness and preparation.
• BP PV CAPAs communication, working on deliverables and closure.
• PV Qualification of LDs/SPs.
• Execution of the annual PV audit plan by conducting LD/SP audits.
• Generating the PV audit reports for the LD/SP conducted audits.
• Perform the CAPA effectiveness check for each closed observation of the LD/SP audits.
• Writes, creates, updates and support in PV SOPs and Polices.
• Prepare KPIs for the critical and major PV activities with NBP.

PV training:

• Update the PV training materials including the presentation and quiz/ upload on NBP Academy LMS.
• Create, update PV SOPs quizzes for relevant internal functions, ensure all take the quiz and document the results.
• Conduct internal onboarding PV training for every newly hired NBP employee.
• Conduct internal PV annual refresher and annual quiz along with documenting results as well as repeating the training for those who failed the first training

PV-RA interface:

• Main PV responsible person for RA/PV alignment monthly meeting preparation and readiness.
• NDAs preparation and renewal dossiers.
• Communicate with NBP RA for different variations, renewals for any PV required documents.
• Back-up support in the annual conference/alignment meeting with all LDs/SPs to close any gaps and share updates.