Regional PV Manager

Objective of the Role:

The Regional PV Manager will be responsible for a cluster of countries, depending on a location, and will ensure that all PV activities in these countries are performed with all necessary requirements, laws and compliance SOPs.  These PV activities include Adverse Event reporting and any necessary literature searches in each of the markets under the Manager’s responsibility.  Due to the unpredictable nature of the number of AEs that may be reported in any given market, the PV Manager may from time to time be asked either to work on markets not necessarily under their normal control; or to absorb other Regional PV Managers into one of more of their markets.

Role can be based in any CEE country; preferably in Poland, Czechia and Hungary.

 

Job specific tasks and responsibilities for each activity:

 

The following activities will either be performed by the Regional PV Manager or the employee will manage an external agency/ies which will conduct these tasks:

• Establishing and maintaining pharmacovigilance system and procedures covering all activities required by local regulations and safety agreements with manufacturers
• Collection, recording, and reporting of Adverse Events (AEs) and Safety Information to Manufacturers (including translation, if needed)
• Conducting follow up with reporters (in accordance with local regulations or upon request from the manufacturer)
• Handling of AEs related to Quality Complaints and Medical Queries
• Expedited regulatory reporting to the regulatory authority (in accordance with local regulations)
• Submission of periodic reports to the regulatory authority (in accordance with local regulations)
• Local literature review (if local publications are not included in the global screening)
• Monitoring publications of the regulatory authority
• Reconciliation with partners and internally (customer service/ patient support programs)
• Creating and updating SOPs to cover all PV activities
• Annual training programs to employees (including new employees) and vendors
• Performing and undergoing audits and regulatory inspections
• Risk Management Plan (RMP) implementation, if applicable
• Responding to medical queries from HCPs and consumers
• Deviation management (CAPAs)
• Assessment of ICSRs if required by local regulations

 

Desired profile:

• Pharmacist or PhD in life sciences
• At least 10 years of work experience in the healthcare industry with at least 5 years in a pharmacovigilance role
• Significant experience in the innovative sector of the pharmaceutical industry, ideally with rare disease and/or oncology experience
• Experienced in Microsoft Office (particularly Excel), Microsoft Teams (or related remote conferencing applications) and ZINC (or related document management applications)
• Manages projects or programs with high ethical standards, all in line with the legal requirements and provisions of International and Local Codes of Practice and within the allocated resources
• Identifies problems and proposes innovative solutions. Meets set agreements with customers and colleagues.
• Cross-functional teamwork and collaboration skills are integral to the position.
• Displays the following characteristics: Highly motivated, organised, committed, curious, attention to detail, assertive, empathetic, results oriented, capable to adapt to change and capable to complete tasks that have been started.
• Compelling, structured and inspiring presentation style
• Team player, though capable of working autonomously
• Fluent in English (written and oral)

 

Job Requirements

• Ability to travel in Internationally as required
• Expected travel 10% of working time

Only shortlisted candidates will be contacted