Global Regulatory & PV Strategy Lead

PrimeVigilance; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Job summary

PrimeVigilance is seeking a Senior Specialist, Regulatory and PV Network to drive regulatory deliverables in alignment with PV plans. The role acts as Local PV contact for the designated country and collaborates with clients, authorities and partners to ensure compliance and timely delivery.

The successful candidate will lead projects of medium/high complexity, develop strategies, manage setup activities, and support proposal development and budgets within a global pharmacovigilance setting.

Qualifications

• Bachelor’s degree in a relevant life sciences field with regulatory or PV exposure.
• Experience in pharmaceutical/CRO regulatory environments or with regulatory bodies.
• Knowledge of ICH GCP, GVP, and national regulations for territories of competency.
• PV training or work experience and related local requirements.
• Proficiency in English (written and spoken) and local language.

Responsibilities

• Act as Local Contact Person for Pharmacovigilance for the designated country.
• Lead regulatory deliverables and coordinate with project teams to meet targets.
• Develop strategy and manage setup activities (MAPs, SOPs, core docs).
• Provide input to clients and address risks with preventive measures.
• Monitor budgets, timelines, and escalate OoS when needed.
• Prepare client invoices and support budgets and BD meetings.

Skills

Fluent English

Interpersonal skills

Planning & organization

Regulatory liaison

Problem solving

Education

Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent

Job description

PrimeVigilance is seeking a Senior Specialist, Regulatory and PV Network to drive regulatory deliverables in alignment with PV plans. The role acts as Local PV contact for the designated country and collaborates with clients, authorities and partners to ensure compliance and timely delivery.

The successful candidate will lead projects of medium/high complexity, develop strategies, manage setup activities, and support proposal development and budgets within a global pharmacovigilance setting.