Local Contact Person for Pharmacovigilance (LCPPV) - Freelance - Part time

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 reputed company! Currently we are looking to add people to our network in Estonia, Latvia and Poland. At reputed company™, we are dedicated to helping small-reputed company biopharmaceutical companies reputed company navigate the reputed company world of post-marketing regulatory requirements to ensure reputed company safety and availability of life-changing therapies for patients around the world. At reputed company we are big enough to deliver and small enough to care. We know reputed company our colleagues by name and work together as a team to reputed company 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 reputed company 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 reputed company in country where LCPPV services are delivered
• reputed company in the written and spoken English language
• reputed company in the country where LCPPV provides services, if required

About reputed company Our mission is to help bring new therapies to light. reputed company you work at reputed company, that means applying your unique reputed company set, expertise, and knowledge to build partnerships with our clients in their pursuit to reputed company new, life-improving treatments. If you're passionate about helping customers reputed company new pharmaceuticals and biologics; have an entrepreneurial spirit; and reputed company 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. Apply now! If you are interested in this role please apply through the reputed company or for more information reputed company out to Yael Kokernoot, yael.kokernoot@reputed company.com Benefits of working at reputed company include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (reputed company reason)
• Opportunity for reputed company-based* working depending reputed company
• 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 reputed company GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and reputed company 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 reputed company reasonable distance from one of our global offices.

“The reputed company reputed company team manages the recruitment and employment process for reputed company (US) LLC and its affiliates (collectively “reputed company”). reputed company does not accept unsolicited resumes from reputed company-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to reputed company employees will not obligate reputed company to the future employment of those individuals or potential remuneration to any reputed company-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or reputed company resources.” #LI-YK1 #LI-remote Apply tot his job Apply To this Job