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We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. 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 market development and any action of effective product maintenance.

 

Senior Specialist Pharmacovigilance


Your Job

Provision of pharmaceutical expertise in the entire field of pharmacovigilance

Case management
  • Management of safety-relevant information 
  • Case processing (data entry), including translation Portuguese/English and quality check of translation;
  • Data entry quality check (without case assessment);
  • Support in the generation, processing and tracking of follow-up requests;
  • Handling of Customer enquiries or complaints in the scope of literature surveillance and case processing, according to quality assurance requirements;
Role of Local Contact Person for Pharmacovigilance (LCPPV):
  • Responsible for the establishment and maintenance of the Marketing Authorisation Holder’s (MAH) local pharmacovigilance (PV) system, and for the performance of local PV operations;
  • Act as the local (Portuguese) contact point for PV issues at the Competent Authority on behalf of the MAH;
  • Acting as a single contact point for the Competent Authorities on a 24-hour basis and be permanently and continuously at disposal of the MAH.
  • Maintain knowledge of local regulations and medicinal Product’s authorised in the territory (PV Regulatory Intelligence);
  • Inform the MAH about local PV regulations changes, as they occur;
  • Interface between MAH (i.e. EU-QPPV and/or global PV team) and the local Competent Authority;
  • Ensure the translation of safety reports received (Portuguese/English), when needed;
  • Participate in PV-relevant Inspections and Audits;
  • Whenever needed, prepare responses to requests for information (safety requests) from regulatory authorities, health professionals, consumers and others;
  • Ensure any local SOPs are established, as required;
  • Collaborate in the implementation of local PVAs;
  • Ensure PV training of MAH affiliate employees in Portugal;
  • Provide support to the MAH in the implementation of additional Risk Minimization Measures (DHPC, Educational Materials, etc.) applicable for the MAH’s medicinal products;
  • Reviewing materials relating to local post-authorization safety;

Quality systems
  • Perform multiple tasks related to Quality Systems, such as writing/Review of procedural documents, support CAPA root cause investigation and CAPA implementation, among others.


Your Profile

  • Medical Documentation specialist or University degree in Life Science
  • Degree in Life Science or equivalent with proven expertise and experience in GxP and / or Pharmacovigilance (GVP) and related aspects
  • 1-2 years of experience in the field of pharmacovigilance
  • Detailed knowledge regarding project-related SOPs (internal and client-specific), global PharmaLex SOPs and pharmacovigilance related SOPs
  • Ability to organize operating procedures
  • Professional verbal and written communication skills with internal and external clients
  • Fluent in Portuguese and English
  • Attention to detail and quality oriented working style
  • Self-confidence and assertiveness
  • Confidence to work alone as well as in a team
  • Strategic, analytical and structured thinking
  • Ability to assimilate and analyse information rapidly
  • Flexibility and adaptability
  • Ability to adjust rapidly to new, unknown, challenging situations



If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

Agencies only by prior agreement for the specific job opportunity.