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Pharmacovigilance and Regulatory Affairs Specialist
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Industry

Life Science

Category

Research & Development

Experience

Entry level

Applications are considered on a rolling basis

Location: Gothenburg +3 more

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Job Description

We are growing, grow with us!

Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? PharmaLex is one of the leading service providers for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance, and development consulting.

In the Nordics we are looking for motivated, committed candidates to join our Pharmacovigilance and Regulatory Affairs department in Sweden.

Your Job
The responsibilities will be dependent on the candidate previous experience, but will be within one or more areas as follows:

Regulatory

  • General guidance (consultancy) of customers regarding Regulatory Submissions & Labelling
  • Participation in the preparation, revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling)
  • Communication with the client and the Health Authorities
  • Regulatory planning, advising and implementation of marketing authorisation application procedures in the EU (MRP, DCP, CP, and national)
  • Regulatory life cycle management procedures (variations, renewals, MAH transfer etc.) worldwide

Pharmacovigilance

  • Participate in pre- and post-market drug safety projects

  • Management of adverse drug reactions from marketed products and clinical trials, including receipt, data entry, review, and reporting of cases

  • Medical information activites, including intake follow up of adverse events, product enquiry and complaint handling from Swedish patients and healthcare professionals

  • Production and review of periodic safety re-ports and risk management plans

  • Literature search

  • Set-up and maintain global pharmacovigilance systems

  • General guidance (consultancy) of customers regarding pharmacovigilance regulations and handling
Skills & Requirements

Your Profile

We are looking for people who have experience working within either Regulatory Affairs, Pharmacovigilance, or clinical studies, but also life science graduates who are passionate about learning.

Requirements

  • Academic degree in pharmacy or life science
  • Well organized and sense of accuracy
  • Service minded, flexible, and committed to meeting deadlines
  • Fluency in spoken and written Swedish and English
  • Team player

We offer

  • Opportunity to conquer exciting and varied challenges alongside an experienced and talented team in a dynamic company
  • External business interaction with clients and internal collaboration within the PharmaLex organization
  • Broad range of initiatives for personal development and professional training
  • A friendly and openminded work environment in a global organization
About the company

PharmaLex is one of the leading service companies for the pharmaceutical industry globally and is specialized in all aspects of drugs and medical devices approval, of the development to market and any action of effective product maintenance. PharmaLex values includes international mindset, growth & learning, collaboration, quality focus, dynamic working approach and integrity & respect.

I'm interested