Drug Safety Associate (DSA)
Location: Budapest, Hungary
The DSA will be responsible for all pharmacovigilance activities, taking care of the pharmacovigilance operational activities including safety case management, aggregate reporting and pharmacovigilance agreements. The job responsible person will ensure that all ongoing Pharmacovigilance activities will be conducted in line with the company policy, SOP’s strategies and adhering to health authorities’ regulations. The Drug Safety Associate (DSA) will report to the Director Pharmacovigilance
Roles and Responsibilities:
- Provides safety support and surveillance throughout the product lifecycle (Pre- / Post-authorization).
- Oversight of day to day safety monitoring activities and safety operations for all investigational and marketed products
- Having a well- developed experience for ensuring compliance of pharmacovigilance system and its quality system via good compliance Management and gap analysis
- Ensuring oversight of the company vigilance system in pre- and post-authorization phases and adhere to company strategic plans, ensuring cost-effectiveness.
- Responsible for the day to day functions such as safety case management (AEs / SAEs / SUSARs) including data triage and case validation assessment, data processing in the safety database (Data entry and MedDRA & WHODD coding)
- Fulfilling expedited safety case (SAEs / SUSARs) reporting requirements for ICH & EMA & FDA and local health authorities.
- Initiating the required communications of relevant safety profile products’ information to internal stakeholders / collaborates and with the co-license business partners.
- Effective participation in the project related team meetings, tele-conferences, and any other ad-hoc safety meetings whenever required.
- Maintaining Safety Data exchange agreements (SDEAs) and SLA with co-license partners, distributers and local safety units.
- Initiating Requests for follow up safety case-relevant information.
- Capable to develop and manage the literature search strategy and validating safety cases for reporting or to refer to the aggregate reports,
- Preparation of safety aggregate reports such as DSUR, RMP, PRBER, PAERs, CSR and the clinical part of dossier for regulatory submission and documentation management.
- Responding to queries from Health Authorities (HA), authorized Representatives and safety partners.
- Performing timely safety data reconciliation.
- Ensure active collaboration with external and internal stakeholders, fulfilling the ongoing projects’ requirements.
- Develop internal procedures, working instructions including Templates and Forms.
- Fulfilling good documentation practice by appropriate managing project-relevant documentation.
- Life Science degree (pharmaceutical sciences, biomedical sciences).
- Prior work experience in the field of pharmacovigilance and drug safety in pharmaceuticals or in CRO organizations
- Good working knowledge of Pharmacovigilance regulations and relevant health authorities’ regulations.
- Well-established working experience in safety case management (SAEs / SUSARs) and data entry in safety database (Arisg and / or Argus) and Safety case submission to EMA to FDA.
- Previous working experience in signal detection and Risk management, applying appropriate tools and methodologies is a plus.
- Good Knowledge of medical terminology: MedDRA, Who Drug dictionary.
- Fluent in English Language and other languages is a plus.
- good computer skills including MS Windows, Word, Outlook
- High sense for quality, accuracy and details-oriented.
- Solid analytical and problem-solving skills.
- Good communications skills with other stakeholders.
- working with priority, can demonstrate working independently.