Pfizer is a research-based, global biopharmaceutical company. We apply science and our global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.
PURPOSE OF THE ROLE
The Compliance Specialist is responsible for the execution of all tasks related to license management and administration of controlled substances, Controlled substances being narcotics, psychotropics and precursors. The Compliance Specialist will be the liaison between the Logistic Center (LC) Operations, the Logistic Service Providers (LSPs) and the Ministry of Health (MOH).
Through smooth coordination the Compliance Specialist will ensure that all activities are performed according to the GDP/GMP and Pfizer quality standards.
* Maintain and follow up on messages in the dedicated mailbox, send out and follow up on communications as appropriate.
* Providing timely and appropriate feedback to the MOH.
* Responsble for maintaining, updating and renewal of the global Pfizer license called 'organisatieprocedure'.
* Responsible for the correct and timely application of import and export licenses.
* Request new customer codes and MOH codes for new product presentations from the MOH.
* Ensure timely endorsement of import & export licenses that have not been used.
* Ensure timely follow up of expired licenses.
* Return of expired import licenses to the markets.
* Link Belgian Import & Exprt licenses in SAP.
* Prepare documents for outgoing shipments of controlled substances.
* Requesting inspections by MOH for outgoing narcotic shipments, or incoming narcotic shipments as appropriate.
* Creation, follow up and handling of NDOF (verdovingsbonnen).
* Maintain and update all existing trackers related to controlled substances on a daily basis as appropriate.
* Provide support on legal control errors in SAP/GTS and SAP.
* Provide classification and MOH data for new materials and new routing setups through Belgium plants to the Intercompany Master Data Team (ICMD).
* Follow up on change requests.
* Ensure accurate maintenance of Standard Operating Procedures (SOPs), Work Instructions (WIs) and Scripts.
* Bachelor degree, university degree or equivalent through experience.
* Ideally 3 years of experience related to administrative handling of controlled substances, having a good knowledge of the rules and legislation linked to this.
* Excellent communication skills.
* Stress resistant and ability to deal with pressure in order to meet set targets and deadlines.
* Ability to work cross functional teams internally and external to the organization.
* Enabler of Own IT culture, Straight Talk and Straight Listening.
* Seeks and strives for permanent improvement.
* Ensures high level of accuracy and quality work.
* High level of self-motivation, energy and flexibility coupled with good relational skills.
* Strong verbal and written skills in Dutch (mandatory) , English and French.
* Broad PC skills are essential. MS office Excel, Powerpoint, Visio, Word are mandatory. SAP Knowledge.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Belgium - Zaventem