Pharmacovigilance Assistant

Randstad Türkiye

We are looking for a ''Pharmacovigilance Assistant'' for our global business partner operating in pharmaceuticals sector and located in Üsküdar.

Qualification Requirements:

• Bachelor’s degree in Pharmacy (fresh graduate)
• Excellent communication (written and verbal), interpersonal, time management, prioritization, organizational and negotiation skills.
• Professional knowledge of English including medical terminology.
• Having a detail-oriented, investigative personality.

General Responsibilities and Regulatory Compliance:

• Execute pharmacovigilance activities as nationally required (such as: adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).
• Monitor national pharmacovigilance legislation.
• Ensure appropriate interpretation and implementation of national pharmacovigilance
• legislation/regulation for both drugs and devices.
• Responsible for appropriate communication between product safety locally, globally, and other relevant stakeholders (product complaints, medical and regulatory affairs).
• Has awareness and provides input to local Risk Management Plans, local risk minimization activities and local Post Safety Authorization Studies as applicable.
• Ensure local business alliance and third-party safety agreements are followed as
• required.
• Support in local training (initial and/or refresher) for employees and/or business
• alliance partners to raise the awareness of pharmacovigilance, as required.
• Support in other pharmacovigilance documents requiring submission to the
• national authority and Ethics Review Board as required (such as: periodic reports).

Adverse event (AE) management responsibilities:

• Serve as point of contact for reception and collection of AE reports.
• Adverse event/device case entry into the safety database.
• Ensure that all relevant information is captured and forwarded to global team within the designated timeframe, both for initial and follow-up reports.
• Responsible for the accuracy and completeness of information reported from clinical trial, post marketing study and spontaneous adverse events for marketed products and devices.
• Complete case follow-up as directed or required.
• Supporting in generating and submission of the necessary case reports that are required for expedited reporting to the Ministry of Health (MoH).
• Reconciliate case reports with business partners, medical information, and product
• quality.
• Archive case source documentation.

Standards and Inspection Readiness:

• Strive for inspection and audit readiness and participate in aligned local inspections, audits, and assessments.
• Ensure relevant safety standard operating procedures (SOP) are well understood
• across the affiliate, lead and provide clarification on local implementation where
• applicable.
• Support the development of global SOPs to ensure alignment with local laws and
• regulations.
• Responsible for ensuring compliance with MoH requirements and global policies,
• procedures, and processes.

Randstad is a private recruitment agency with license number 191 dated 17.10.2006 of the Turkish Employment Agency.