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Medical Shared Services Assistant

03/02/2020
- Brussel

Job content

The purpose of the Medical Shared Services Assistant is to assist the local legal contact for Pharmacovigilance and the Medical Affairs Director to ensure legal duties are executed within the required timelines. You will collaborate with the Medical Affairs team and support them with project management, database management, implementation and follow up of selected medically owned projects.

In addition, the Medical Shared Services Assistant serves as Drug Complaint technician, compiles complaints from Belgium and Luxembourg, coordinates follow-up and entry into Complaints database and reports issues and concerns to the Complaint Coordinator.

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

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

Profile

• At least a bachelor degree (in health sciences)

• 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

• At least a bachelor degree (in health sciences)

What do we offer?

• A contract of limited duration of 1 year at our client, 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

Contact

Aline Vandermeeren +32 16 30 95 09