Senior Pharmacovigilance Specialist

Employers from Greece; United States; Remote; USD 67,000 - 101,000; Full time

Benefits offered by this job

Bonus based on annual performance

Remote/home based

International team and environment

Team building, global meetings

Job summary

Biomapas is seeking a Senior Pharmacovigilance Specialist to support global and local PV systems and ensure compliance with PV activities under international and local regulations. The role may take on additional regional PV responsibilities for simpler systems.

The position is remote, home-based in any EU country. All CVs must be submitted in English for consideration.

Qualifications

• Biologist, Pharmacist, Medical Doctor, or other life science degree.
• 4-year experience in global Pharmacovigilance activities.
• Fluent English.
• Computer literacy (MS Office), experience with PV databases (Veeva Vault Safety is an advantage).
• Strong organizational and time management skills.
• Ability to work independently and in a team.
• Strong communication and relationship-building across teams.

Responsibilities

• Act as the Project Manager or deputy Project Manager for the assigned projects.
• Forecasting and contribute to budget planning for the QPPV Office.
• Update SOPs and serve as PV SME in company processes.
• Maintain KPI reports and perform core PV activities for partners.
• Manage Full or local PV systems and projects and central PV activities.
• Act as customer contact point and ensure effective escalations.
• If applicable, serve as EU QPPV or deputy EU QPPV.
• Ensure PV service quality and timely communication with Health Authorities.
• Ensure inspection/audit readiness and remediation of findings.

Skills

Fluent English

MS Office

PV databases

organizational skills

time management

independent working

Education

Biologist / Pharmacist / Medical Doctor or life science degree

Tools

Veeva Vault Safety

Job description

at Biomapas

Join our global Pharmacovigilance team as a Sr. Pharmacovigilance Specialist.

SeniorPharmacovigilance Specialist is responsible forsupporting global and local PV systems and ensuring compliance with all PV activities with international or local regulations. May overtake additional regional or local PV responsible person roles for simple PV systems.

The position is remote, home-based in any EU country.

All CVs must be submitted in the English language for consideration.

Responsibilities:

• Act as the Project Manager or deputy Project Manager for the assigned projects
• Perform accurate forecasting and contribute to budget planning, ensuring efficient functioning of the QPPV Office
• Update SOPs and act as a subject matter expert for PV in assigned company processes
• Maintain KPI reports and perform core and standard PV activities for assigned contractual partners.
• Manage Full or local Pharmacovigilance systems and projects (or part of them) and/or central pharmacovigilance activities (e.g. end-to-end case processing, Aggregate Safety Reports, Risk Management Plans and risk minimization activities) in both pre- and post-authorization setting (as applicable)
• Act as a customer contact point (where applicable), ensuring consistent communication and escalation management across assigned projects
• Act as the appointed EU QPPV or deputy EU QPPV in accordance with a separate QPPV Job Description (if applicable)
• Ensure high-quality performance of PV services in assigned region/country and timely communication with Health Authorities
• Ensure inspection/audit readiness and finding remediation

Requirements

• Biologist, Pharmacist, Medical Doctor, or other life science degree
• 4-year experience in global Pharmacovigilance activities
• Fluent English
• Computer literacy (MS Office), experience with PV databases (Veeva Vault Safety experience is an advantage)
• Strong organizational and time management skills
• Ability to work independently and in a team
• Strong organization, prioritization, and time management with reliable delivery of commitments
• Strong communicationand relationship building skills across functional teams

Benefits

• Professional growth and career opportunities
• International team and environment
• Bonus based on annual performance
• Personal accident and business trip insurance
• Additional health insurance
• Remote/home based
• Rewarding referral policy
• Workplace establishment allowance (fully remote)
• Team building, global meetings, B active events