Local Contact Person for Pharmacovigilance (LCPPV) - Freelance

Allucent; Poland; On-site; PLN 120,000 - 180,000; Full time

Job summary

Allucent in Poland seeks a Local Contact Person for Pharmacovigilance (LCPPV) to coordinate and perform logistics of PV activities in post-marketed programs, ensuring local regulatory compliance. The role may back-up EU QPPV and requires monitoring of local legislation and safety information.

Ideal candidates hold a university degree in life sciences with at least two years in pharmacovigilance post-marketing activities, fluent English, and residency where PV services are delivered.

Qualifications

• University degree in medicine, pharmacy or life sciences with at least 2 years of pharmacovigilance post-marketing experience.
• Fluent in written and spoken English.
• Residence in the country where LCPPV services are provided, if required.

Responsibilities

• Acts as the primary point of contact for local regulatory authorities, including 24/7 if legally required
• Monitors safety issues and regulatory updates related to client products
• Supports audits and inspections, providing documentation and CAPAs as needed
• Performs local literature screening and collection of safety information
• Assists in developing or reviewing the local pharmacovigilance system master file (LPSMF)
• Supports local signal detection and local risk minimization measures
• Manages reporting to EU QPPV and communications with local PV stakeholders
• Reviews local PV agreements upon request
• Provides local PV training to sales force, affiliates, and distributors
• Produces monthly activity reports on PV system status

Skills

Fluency in English

Education

University degree in medicine, pharmacy or life sciences

Job description

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.