Pharmacovigilance Specialist

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? Then, PharmaLex is your career choice!
PharmaLex is part of Cencora - the leading service provider for the pharmaceutical, biotech and medical device industries globally. PharmaLex is specialized in effectively designing all aspects of drugs and medical devices regulatory needs, ranging from early development and market entry to product maintenance activities.

We are looking for an additional team member to join us in Bulgaria.
A great opportunity for a Pharmacovigilance expert who would like to work on many exiting client projects.

Pharmacovigilance Specialist - French speaking

*** This is an opening for French speaking professionals in Bulgaria ***

Your Job

• Management of safety-relevant information from all sources (including, but not limited to spontaneous, literature, clinical studies, medical information enquiries)
• Case processing (data entry), including translation French/English and quality check of translation
• Data entry quality check (without case assessment).
• Screening of local scientific literature (safety relevant publications), including creation of search algorithms for local literature screening
  Support with creation of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and from the literature; reporting of ICSRs to the competent authorities
• Documentation of case processing on a company and a case level
• Support in the generation, processing and tracking of follow-up requests
• Prepare and perform monthly reconciliations and monthly PV intelligence for clients
• Fill in and maintain up to date PV trackers (including but not limited to PV cases trackers, local literature trackers, monthly PV reports trackers)
• Translation French/English in the context of case processing, including quality checks of translations

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
• 0-2 years of experience in the field of pharmacovigilance
• Excellent knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
• Detailed knowledge regarding project-related SOPs (internal and client-specific), global PharmaLex SOPs and pharmacovigilance related SOPs
• Ability to organize operating procedures and to take over project management duties
• Professional verbal and written communication skills with internal and external clients
• Fluent in French, English
• Excellent written and verbal communication skills
• Confidence to work alone as well as in a team
• Strategic, analytical and structured thinking
• Ability to assimilate and analyze information rapidly
• Flexibility and adaptability

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.

For further information please don't hesitate to contact us.

 

Agencies only by prior agreement for the specific job opportunity.