Local Contact Person for Pharmacovigilance (LCPPV) - Freelance

Allucent; Polska; Teletrabalho; PLN 96 000 - 165 000; Tempo parcial

Resumo da oferta

Allucent is seeking a Local Contact Person for Pharmacovigilance (LCPPV) in Poland to coordinate and perform logging and regulatory tasks for post-marketing programs. The role may back-up PV managers and ensures compliance with local requirements.

The candidate should have a University degree in medicine, pharmacy or life sciences and at least 2 years of pharmacovigilance post-marketing experience, with fluent English and willingness to reside in Poland if required.

Qualificações

• Minimum 2 years of pharmacovigilance post-marketing experience.
• Fluency in written and spoken English.

Responsabilidades

• Acts as the primary point of contact for local regulatory authorities, including 24/7 if required
• Monitors safety issues and regulatory guidance for client products
• Monitors changes to local PV legislation
• Supports client audits and inspections with documentation and CAPAs as needed
• Performs local literature screening and safety information collection
• Assists on developing or reviewing the local pharmacovigilance system master file
• Supports local signal detection where applicable
• Manages local risk minimization measures
• Reports to the EU QPPV and maintains regular communication
• Supports review of local PV agreements as requested
• Performs local PV training to sales, affiliates and distributors
• Provides monthly activity reports on PV status

Conhecimentos

Pharmacovigilance experience

English proficiency

Formação académica

University degree in medicine, pharmacy or life sciences

Descrição da oferta de emprego

We’re building a local network of talented PV experts to collaborate with on future projects. We’d love to connect with professionals who are interested in staying in touch for freelance (parttime) opportunities. Currently we are looking to add people to our network in Poland.

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of post-marketing regulatory requirements to ensure continued safety and availability of life-changing therapies for patients around the world. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE.

The role

The Local Contact Person for Pharmacovigilance (LCPPV) coordinates and performs the logistical aspects of pharmacovigilance activities in post-marketed programs to ensure compliance with local requirements. This position controls and monitors operational pharmacovigilance activities and may back-up Pharmacovigilance Manager(s) as required.

Main responsibilities:

• Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required
• Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class
• Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance
• Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed
• Performs local literature screening and collection of safety information
• Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required
• Supports local signal detection, if applicable
• Manages locally risk minimization measures, as applicable
• Reports to and maintains regular communication with the EU QPPV
• Supports the review of local PV agreements, if requested
• Performs local PV training to eg. sales force, affiliate personnel, distributors
• Provides monthly activity report on status of local PV system

Who are we looking for:

• University degree, preferably in medicine, pharmacy or life sciences and minimum 2 years of experience in the performance of pharmacovigilance post-marketing activities
• Have up-to-date knowledge of applicable global and local regulatory requirements
• In-depth knowledge of the pharmacovigilance legal framework in country where LCPPV services are delivered
• Fluency in the written and spoken English language
• Reside in the country where LCPPV provides services, if required

About Allucent

Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.

Together we SHINE. Find more information about our values.

Disclaimers:

The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.