Local Contact Person, Pharmacovigilance – Freelance, PT

This is a fully remote position, open to applicants in Poland.

📋 Description

• Serves as the main contact for local regulatory authorities, including 24/7 availability when legally mandated.

• Keeps track of safety concerns and recommendations from local regulatory authorities related to client products or product classes.

• Stays informed about modifications to local legislation regarding pharmacovigilance.

• Assists with client audits and inspections as necessary, including attending, providing requested documents, and completing Corrective Actions and Preventive Actions (CAPAs) if required.

• Conducts local literature screening and gathers safety information.

• Aids in the creation or review of the local pharmacovigilance system master file (LPSMF) if needed.

• Provides support for local signal detection, when applicable.

• Oversees local risk minimization measures, as relevant.

• Reports to and maintains consistent communication with the EU QPPV.

• Assists in reviewing local PV agreements upon request.

• Delivers local PV training to personnel, such as the sales force, affiliate staff, and distributors.

• Submits a monthly activity report detailing the status of the local PV system.

⛳️ Requirements

• A university degree, ideally in medicine, pharmacy, or life sciences, along with a minimum of 2 years of experience in executing pharmacovigilance post-marketing activities.

• Possesses current knowledge of relevant global and local regulatory standards.

• Extensive understanding of the pharmacovigilance legal framework in the country where LCPPV services are provided.

• Proficiency in both written and spoken English.

• Must reside in the country where LCPPV delivers services, if necessary.

🏝️ Benefits

• Comprehensive benefits package tailored to the location.

• Competitive salaries based on location.

• Departmental Study/Training Budget to enhance professional development.

• Flexible working hours (within reasonable limits).

• Opportunities for remote or office-based working depending on location.

• Leadership and mentoring prospects.

• Involvement in our enriching Buddy Program for new or existing employees.

• Internal growth opportunities and career advancement.

• Financially rewarding internal employee referral program.

• Access to online soft-skills and technical training through GoodHabitz and internal platforms.

• Eligibility for our Spot Bonus Award Program in recognition of exceptional project contributions.

• Eligibility for our Loyalty Award Program to honor long-term employee commitment and loyalty.