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.
*** This resource will be working in flexible hybrid model, hence office attendance is required (Paris) ***
Provision of operational tasks and expertise in the entire field of pharmacovigilance.
Depending on the assigned pharmacovigilance projects, the main tasks are:
- Management of safety-relevant information (level 1) 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).
- Contribution to the 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; management of cases as per projects specific requirements
- Documentation of cases
- 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
- Assistance in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), risk management plans and signal detection reports if relevant as per Line managers guidance
- 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)
- Receipt and management of Level 1 Medical Information enquiries via the PharmaLex Integrated Medical Information System, including triage for relevant area (pharmacovigilance and/or medical information and/or/product quality complaint) and data entry including translation German/English.
- Availability for phone calls during the project-specific business hours
- Regular monitoring of dedicated data entry sources
- Responding to 1st Level MI enquiries according to approved reference documents
- Escalating 2nd Level MI enquiries and other type of information
- Perform quality control tasks as per projects requirements
- Degree in Life Science or equivalent with proven expertise and experience in pharmacovigilance (GVP) and related aspects
- 1-2 years of experience in the field of pharmacovigilance
- Excellent knowledge of relevant regulatory local and EU 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
- French language native level; good skills in written , spoken, and writing English
- Excellent written and verbal communication skills
- 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.
For further information please don’t hesitate to contact us.
Agencies only by prior agreement for the specific job opportunity.