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. Let’s start the conversation and build a connection! 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
Requirements
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.
Benefits
Benefits of working at Allucent include:
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/office-based* working depending on location
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices.
“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.”
Skills Required
- University degree in medicine, pharmacy, or life sciences
- Minimum 2 years' experience performing post-marketing pharmacovigilance activities
- Up-to-date knowledge of applicable global and local pharmacovigilance regulatory requirements
- In-depth knowledge of the pharmacovigilance legal framework in the country where services are delivered
- Fluency in written and spoken English
- Ability to act as primary local contact for regulatory authorities, including availability 24/7 if legally required
- Experience supporting audits and inspections and completing CAPAs
- Residency in the country where LCPPV services are provided (when required)
What We Do
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
