Medochemie is an International Pharmaceutical Company, one of the top 200 producers of generic drugs globally, exporting its products to 110 countries, thus holding the 29% of the total industrial exports of Cyprus. Medochemie operates 13 ultramodern manufacturing plants, 9 in Cyprus, 3 in Vietnam and 1 in the Netherlands, all designed in accordance with GMP (Good Manufacturing Practice) of the EU and WHO (World Health Organization, operates in 22 countries and employs a global workforce of 1880 employees of 19 ethnicities.

As part of our commitment to patient safety and regulatory compliance, we are looking for an experienced Pharmacovigilance Specialist to join our team and help us ensure the continued safety of our products.

What the job looks like?

The Pharmacovigilance Specialist will have the opportunity to:

• Monitor and assess adverse drug reactions (ADRs) for the company's portfolio of generic medicines.
• Ensure timely and accurate submission of individual case safety reports (ICSRs) to Eudravigilance accordance with EU regulations.
• Collaborate with cross-functional teams (Quality Assurance, Regulatory Affairs, Medical affairs) to support safety data management and risk mitigation strategies.
• Maintain and update pharmacovigilance databases in compliance with Good Pharmacovigilance Practices (GVP).
• Prepare periodic safety update reports (PSURs), risk management plans (RMPs), and other safety documentation for regulatory submissions.
• Conduct signal detection and benefit-risk analysis for products on the market.
• Participate in pharmacovigilance audits and inspections, ensuring compliance with local and international regulatory requirements.
• Support the Pharmacovigilance Quality system by providing trainings, updating procedures, prepare and review contractual agreements as well as other quality related responsibilities, as per internal procedures.
• Stay up-to-date with changes in EU pharmacovigilance regulations and guidelines to ensure company-wide adherence.

What does it take to do the job?

• University degree in a Health-related field, including Pharmacy, life sciences or other related field.
• At least 2 years of experience within the pharmaceutical industry in pharmacovigilance, drug safety or regulatory affairs, preferably within the generic industry.
• Good knowledge of EU pharmacovigilance regulations, including GVP and ICH guidelines.
• Strong analytical skills with a focus on detail and accuracy.
• Excellent written and verbal communication skills in Greek and English.
• Ability to work independently and within a team, managing multiple projects under tight deadlines.
• Excellent computer literacy (MS Office)

By joining us you can expect:

• A unique opportunity for a career in a fast-growing company

• Competitive remuneration package based on qualifications and experience
• 13th Salary
• Paid Vacation
• Modern & Professional Work Environment
• Multiple events to bond with the team
• Participation in the Company’s Provident fund where the employer contributes 7% of the monthly salary
• Optional participation in the Company’s Group Medical Scheme, and Discount Scheme
• Opportunities to learn and develop yourself through our ‘Employee Training & Development Path’

If you believe that you have the above qualifications and this position sounds challenging, submit your application through the link below:

http://www.medochemie.com/MainMenu/Careers.aspx

Applicants should note that based on the General Data Protection Regulation (GDPR), all applications/CVs are kept in our database based on the consent period each candidate applied for. In case you have forwarded us your CV in the past and you are interested in this position, please apply again.

Department: Pharmacovigilance

Location: Limassol

Employment Status: Full Time

All applications will be treated with strict confidentiality. Only shortlisted candidates will be contacted.