Regulatory Affairs & Pharmacovigilance Specialist

MagnaPharm Baltics, UAB

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Job Opportunity: Regulatory Affairs & Pharmacovigilance Specialist

Join a Leading Pharmaceutical Partner in the CEE Region

Are you an experienced Regulatory Affairs and Pharmacovigilance professional looking for an exciting role in a fast-growing company? Do you want to be part of a dynamic team and make a meaningful impact across the Baltic region? If so, we want you on our team at MagnaPharm!

Position: Regulatory Affairs & Pharmacovigilance Specialist

Location: Vilnius, Lithuania

Sector: Pharmaceutical & Medical Devices

About MagnaPharm:

MagnaPharm is a pharmaceutical outsourcing group and trusted local service provider for multinational pharmaceutical companies across Central and Eastern Europe (CEE). With a team of over 590 professionals, we go the extra mile to fulfill the demands of our reputable partners. Our operations cover a wide range of CEE countries, including Romania, Poland, Hungary, Lithuania, Latvia, Estonia and many more, with plans to expand further. We provide full-scale services to help cosmetic and pharmaceutical companies bring innovative products to market with maximum efficiency and impact. Learn more at www.magnapharm.eu

Key Responsibilities:

Manage Pharmacovigilance (PV) and Regulatory Affairs (RA) activities across Lithuania, Latvia, and Estonia.
Oversee reimbursement activities and ensure compliance with local regulations.
Manage regulatory submissions for medical devices and pharmaceutical products.
Ensure timely collection, processing, and archiving Adverse Drug Reaction (ADR) reports from all sources.
Ensure data entry of ADR reports to the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and other regulatory systems.
Monitor the EudraVigilance system for safety data of medicinal products from Marketing Authorisation Holders (MAHs).
Assess and mitigate regulatory risks associated with commercialization activities.
Prepare and translate local product labeling materials (e.g., SmPC, PIL) from English to local languages.
Review and approve promotional and artwork materials in client systems.
Support of pharmacovigilance training for local teams.

Requirements for Candidates:

Bachelors Degree in Life Sciences or a professional equivalent.
A minimum of 2 years of regulatory expertise, including hands-on experience with country-specific requirements for medical devices and medicinal products.
Proven expertise in managing pharmacovigilance systems, with access to relevant knowledge in medicine or pharmaceutical sciences.
Experience in preparing regulatory submissions, artwork review, and communication with health authorities.
Knowledge of local pharmaceutical legislation (Lithuania, Latvia, Estonia) and relevant guidelines.
Proficient in English, with fluent communication and writing skills in Lithuanian (or Latvian/Estonian).
Strong organizational and communication skills, with a focus on quality and precision.
Ability to work both independently and as part of a team, to coordinate projects with external parties.
Ability to meet tight timelines and manage multiple tasks effectively.

Company Offers:

Competitive Remuneration: Salary range 2000 3000 EUR Brutto, plus annual bonuses.
Supportive Environment: Work within a small, motivated team that encourages collaboration and professional growth.
Growth Opportunities: Take on a leadership role and build your own team as the company continues to expand.

Ready to Elevate Your Career?

If you are excited about this opportunity, we invite you to apply! Send your CV and cover letter.

Be a part of something biggerjoin MagnaPharm and make a difference in the pharmaceutical industry today!

NB! Please note that we will contact only second round candidates who meet the requirements as set above. Provided personal information will be used only for mentioned recruitment project and purposes within MagnaPharm Baltics. After the particular recruitment project, the disclosed data will be deleted.

Mėnesinis bruto atlyginimasBruto/mėn. € 2000 - 3000