PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.

For the Client:

• To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
• To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
• To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• To cooperate in the preparation of and provide input in Risk Management Plans
• Supporting the preparation of responses to regulatory authority requests
• Signalling
• Reviewing line listings
• Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
• Evaluating and categorizing possible signals and proposing a course of action
• Supporting preparation and review of benefit-risk reports

• The PV Physician should be medically qualified as a physician
• 2+ years of work experience in pharmacovigilance
• Ability to review different aggregate report types including PBRERs and DSURs
• Expertise in signal detection activities is essential
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork
• Communication skills  
• Presentation skills
• English - advanced (spoken, written)
• Advanced literacy (MS Office)

Our Offer

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year