2023-04-13 14:47:21
2023-02-22 15:26:30

Pharmacovigilance Manager

CVMarket.lv klients
1500 - 2500 €/mēn. Bruto
Apskatīt sludinājumus

Darba apraksts

We are looking for an Pharmacovigilance Manager, operating in Latvia, who will perform pharmacovigilance activities in Baltics States.


Duties and responsibilities:

  • Write PV-related documents, e.g. PSURs, RMPs, PSMF.
  • Literature monitoring to find safety data.
  • Storage and archive of safety data, experience with PV database.
  • Develop and write PV SOPs.
  • Write safety data exchange agreements (SDEA).
  • Regulatory intelligence in Baltics States.
  • Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy.
  • Provide expert input to strategic decision making, including portfolio review, prioritization, and external communications.
  • Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil all relevant expectations and quality standards

Prasības kandidātiem

  • Bachelor level degree required preferably in chemistry, biology or related life science.
  • 3-5 years related work experience in Latvia, Estonia, and Lithuania in Pharmacovigilance.
  • A clear understanding of European, international and local PV requirements including Good Pharmacovigilance Practices (GPvP)
  • Strong interpersonal skills, ability to communicate and manage well at all levels of the organization and with staff at remote locations essential.
  • High level of written and oral communication skills (Latvian, English and Russian).
  • Ability to work independently and develop ideas and solutions to the department challenges and interface with regulatory bodies and consultants to resolve them.

Uzņēmums piedāvā

  • Work in internationally recognised and growing company.
  • Competitive salary, starting from 1500 Euro to 2500 Euro per month (gross).
  • Possibility to learn working with branches and different currencies.
  • Opportunity to develop professional skills.
  • Interesting, dynamic and responsible work.
  • Working hours during working days from 9.00 to 18.00.
  • Remote work mode from home office.