For one of our partners, we are actively looking for a Medical Assistant - Junior level; the function is divided between two departments: Pharmacovigilance & Medical Affairs.
Are you interested in a first experience in the pharmaceutical industry, are you comfortable with IT tools, are proactive, organized and enjoy teamwork? Read the offer below!
1. Drug Safety
AE receipt and data collection (Belgium/Luxembourg)
- Ensure identification, retrieval, acknowledgment and distribution of Adverse Events (AE) information
- Collect and document all AEs with products reported spontaneously for marketed products and those serious AEs associated with clinical trials and post-marketing surveillance studies
- Responsible for appropriate receipt and managing of AE reports received via Customer Connect, e-mail, fax, letter, phone, in person or through the online AE form
- Report new or follow-up information as it is received
- Ensure completion of action items
- Communicate effectively with AE reporters.
Submission DSURs and other safety reports to Agency (Belgium)
- Responsible for mailing Development Safety Update Reports (DSUR) and other Safety reports to the Agency, following regional guidance.
Submission DSURs and other safety reports to Ethical Review Boards/ERBs (Belgium)
- Responsible for submitting DSURs to ERBs
- Responsible for submitting other safety reports to the applicable ERB.
Safety Mailings to ERBs (Belgium)
- Responsible for generating the necessary expedited case reports (SUSARs) to ERBs that are required to meet local regulatory requirements.
2. Product complaint technician
- Serves as point of contact for receipt and collection of product complaints (PC)
- Ensures identification, retrieval in appropriate sources (Customer Connect, email, fax, letter, phone or in person) and acknowledgment of Complaint information
- Collects follow-up if needed in collaboration with Complaint coordinator
- Enters complaint in Complaints database (TrackWise)
- Supports to TrackWise auto-creation process; affiliate RCP (Responsible Complaint Person) activities includes Reviews PC information (contacts reporter and updates information when needed). Translate PC description if not in English and Assign Complaint Record(s) to the Regional Center for triage and assessment
- Ensures follow-up of complaint (e.g. shipment of product to production site, when applicable)
- Coordinates preparation of letters to customers with complaint coordinator
- Keeps local complaint database updated and coordinate internal communication responsible pharmacist/Complaint Coordinator.
3. Medical Affairs support
- Organize and follow up of internal medical affairs meetings
- Become the VEEVA (Thought leader database, PromoMat) expert and train others in order to increase consistency and productivity
- Coordination of activities and engagement of Thought Leaders, based on input from the Medical Affairs colleague
- Third Party follow up, as needed
- Review translations of trainings and materials
- Identify interesting projects in other countries that could be replicated and work out innovative ideas
- Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts), in collaboration with the Medical Affairs colleague.
Education & Experience
- At least a bachelor degree (in health sciences could be an advantage).
- Strong interpersonal skills, communication, team work, project management and pro-activity
- Ability to effectively partner within different medical teams
- Ability to execute tasks in parallel and prioritize broad deliverables
- Proficiency in computer skills and database entry
- Compliance with all procedural requirements
- Demonstrated success in multi-tasking projects
- Ability to work effectively and share information within a team environment
- Fluent in Dutch and/or French, and English.
They offer you :
- A contract of limited duration of 1 year, which may be renewed
- An exciting culture, based on respect for people, striving for excellence and high integrity
- A work environment based on collaboration and team spirit
- An occasion to be part of a continuous innovating company
- The possibility to invest in your personal development
- Have a high level of autonomy in your daily activities
- A pharma competitive salary & benefit package.
Interested? Don't hesitate to contact me : email@example.com - 028011665