We are hiring! Pharmassist is now in the look for qualified CMC Writers and Senior Drug Safety Officers.

We are now seeking to invest in qualified, enthusiastic professionals who will take up the role(s) of:

CMC WRITER / SENIOR DRUG SAFETY OFFICER

The ideal candidate professionals - for each profile- should consider the following:

CMC WRITER

Positions’ Responsibilities:  

  • Evaluation of technical documents, CMC writing and Compilation of Common Technical Document (CTD) Module 3, required for:
  • Clinical Trial Applications (IMPD)
  • Applications for Marketing Authorisations in Europe and/or Third Countries

•           Authoring of Module 2.3 (Quality Overall Summary)

•           Gap Analyses of existing dossiers and documentation

•           Preparation and compilation of variation packages concerning Module 3 sections

•           Dossier Consolidation and Update based on relevant variations submitted

•           Dossier conversion from NTA to CTD format for old product lines

•           Compilation of Baseline Dossiers

•           Preparation of Response Documents for Questions raised by Regulatory Authorities on CMC matters

•           Regulatory CMC Strategy: Provision of expert regulatory advice to stakeholders

(manufacturing, QC) on technical changes

•           CTD Publishing in eCTD format

Position’s Educational Requirements / Qualifications:

•           Bachelor and/or Master’s Degree or Ph.D. in the area of Pharmacy, Chemistry or Biology

•         At least three years’ experience in Regulatory Affairs and CMC groups in the pharmaceutical industry

•           Knowledge and understanding of regulatory legislation and guidelines related to CMC, procedural and administrative aspects

•           Previous experience in writing scientific / regulatory documents

•           Time management to meet agreed short-term targets

•           Team working skills, including optimal reporting and alerting capabilities

  •  Excellent written and verbal communication skills in English

 To apply please send your CV to:  hr-regulatory [at] pharmassist.gr ()

 

SENIOR DRUG SAFETY OFFICER 

Positions’ Responsibilities:  

•    Assisting with the management of safety reports including data entry, MedDRA coding, quality control and expedited report submission and tracking.

•     Assisting in compilation and submission of aggregate reports

•    Assisting the Senior team in developing metrics to monitor the performance of pharmacovigilance activities; suggest performance improvements

•     Supporting the preparation of RMP and post-marketing safety monitoring activities.

•     Performing the analysis of potential safety signals according to SOPs and guidelines

•     Reviewing Safety Data Exchange Agreement with clients

•     Maintaining the Pharmacovigilance System Master Files (PSMF) and extended Medicinal Product Dictionary

•     Providing drug safety guidance and training to our clients’ employees

•    Insuring procedures in relation to safety monitoring are being adhered to regulatory requirements.

Position’s Educational Requirements / Qualifications:

  • Life Science Bachelor’s degree or higher
  • Knowledge in medical terminology
  • A minimum of 3 years’ experience on PV activities
  • Excellent written and verbal communication skills in English
  • Self-motivated and able to work independently
  • Effective time management skills
  • Excellent knowledge of Microsoft office
  • Capability to problem-solving and managing complex safety issues

 

To apply please send your CV to:  hr-safety [at] pharmassist.gr ()

 

Please note: All information on your application and CV is regarded as highly confidential, is not wholly or partially made public or known to third parties. Only authorized employees or external partners of our company have the right to access your information, which is solely used in order for your qualifications to be objectively evaluated for a future career at Pharmassist LTD. Your application and any other information will be kept in our database for 12 months. In any case, feel free to contact us in order to ask for your CV's earlier deletion or for any other relevant information.

By sending your Curriculum Vitae, you declare explicitly that you agree with and approve the above-mentioned processing of your personal data, as described in the company's Privacy Policy.