Our Client SANOFI – a global healthcare leader and a provider of healthcare solutions in more than 170 countries around the world, is seeking a committed professional at the position

Regulatory and Pharmacovigilance Officer

- contract concluded on a fixed term, as a replacement of an employee going on a maternity leave -

Main duties and areas of responsibility:

• Administrative support in relation to regulatory responsibilities:
  • Preparation of required documentation in respect to new registrations, renewals, variations, including follow up and handling answers to questions and deficiency letters received from the Agency
  • Preparation of needed reports and/or update of data basis
  • Management of documentation – archiving of all submitted documentation to the Agency
  • Preparation of documents required for obtaining import licenses and costs related to registration, renewal and variation of products
  • Validation of translations and packaging materials

• Administrative support in relation to Pharmacovigilance responsibilities:
  • Activities in handling ICSRs and other PV data received locally
  • Preparation of documents required for submitting reports to the GPE and the Agency concerning the local and foreign Individual Case Safety Reports (ICSRs) and adverse effects of the medicinal products and adverse events recorded in clinical and post-marketing trials sponsored by Sanofi, in accordance with the GPE SOPs and relevant local regulatory requirements in the domain.
  • Monitoring daily incoming communication related to local and external ICSRs and adverse events recorded in clinical and post-marketing trials sponsored by Sanofi, to be submitted to GPE and to the Agency for Medicinal Products and Medical Devices
  • Tracking of reporting activities, including submission of PSURs, ICSRs, non-business hours telephone calls related to emergency PV issues
  • Reviewing of local professional and scientific literature for articles involving Sanofi products in order to report potential safety information to GPE
  • Assistance during audit and inspection visit
  • Screening of national regulations in order to be forwarded to GPE Regulatory Intelligence unit

Requirements:

• Graduated pharmacists, previous professional experience in regulatory & pharmacovigilance field of at least 2 years is a strong preference
• Interpersonal skills of diplomacy, knowledge of and respect for cultural differences, professionalism and arbitration, ability to work in international and transversal teams
• Eye for details, problem solving skills, sense of urgency, capacity to work under pressure, multitasking skills.
• Sufficient proficiency in English (verbal and written) to accurately communicate PV information outside his/her country.
• Computer literacy - MS Office (Word, PowerPoint, Excel)

If you are interested and motivated for this position, please send your CV and Cover Letter in English language to [најави се за да го видиш е-маилот] till 24/03/2019. In the subject line of your e-mail please refer to the job title Regulatory and PV Officer.

All applications will be proceeded in strict confidentiality. Only short-listed candidates will be contacted for further interviews. For any questions you might have, please feel free to contact Executive Search Consulting at (02) 2700-425.