Clinical Safety Intern

**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.

**Clinical Safety Intern**

**Your Job**
- Management of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) process: receipt, data entry, narrative writing, request follow up information, medical assessment and expedited or aggregate reporting.
- Data entry of adverse event reports in databases such as ABCube Safety-easy, Argus.
- MedDRA and ATC coding of Adverse Drug Reactions and Adverse Events.
- Reporting of reports that fulfil the criteria for expedited reporting either via validated E2B compliant safety database or through EVWEB, the EMA reporting tool for ICSRs and SUSARs.
- Reconciliation between the SAEs and the clinical study database.
- Submission of Development Safety Update Reports (DSUR).

**Your Profile**
- Bachelor’s degree in Science and related areas or demonstrable experience in Pharmacovigilance.
- Knowledge and familiarity regarding relevant legislative and non-legislative guidelines on pharmacovigilance.
- Knowledge of pertinent medical or pharmaceutical and clinical practice.
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global and local PharmaLex SOPs and pharmacovigilance related SOPs.
- Autonomous, concentrated and high-quality work.
- Ability to assimilate and analyse information rapidly.
- Excellent written and verbal communication skills.
- Ability to work as part of a team and sense of responsibility within the team.
- Ability to self and time management.
- Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
- Self-confidence and assertiveness.
- Fluent English skills.

Agencies only by prior agreement for the specific job opportunity.