Drug Safety Specialist
PPD is a world-renowned and respected clinical research organisation, working with major pharmaceutical and biotechnology companies to provide expertise in discovery, development and post-approval services. Due to its rapid growth and development, we invite you to join our team at the position of:
DRUG SAFETY SPECIALIST
The Safety Specialist will provide technical and process-related expertise to drug safety management, ensuring compliance
with relevant regulations as well as PPD’s Standard Operating Procedures (SOPs), Work Practices (WPs) and Operating
Responsibilities will include tasks related to adverse event processing and reporting
• DATA COLLECTION - ensure accurate entry and coding of SAEs/AEs into the safety database
• ASSESSMENT – perform initial review of adverse events, perform seriousness and relatedness assessments, send
follow-up SAEs/AEs queries to investigator sites or reporters
• REPORTING - create patient adverse event narratives if appropriate; create drafts of aggregate reports (PSURs,
PADERs), assist in the preparation of files for archiving, and transfer to client
The successful candidate will have:
• Medicine, Pharmacy, life-sciences degree or nursing qualification
• High English language proficiency; efficient communication skills in English both written and spoken.
• Hands-on experience with MS Office (Word, Excel and PowerPoint). Database experience will be considered an
• Previous drug safety/ pharmacovigilance experience would be a significant advantage
• Attention to detail and ability to preserve concentration
• Exposure to multi-cultural environment
• Provide an extensive training to gain the expertise you need
• Ensure a working environment of high quality and standards
• Offer a competitive remuneration package
• Give you an excellent opportunity for a challenging and rewarding career
HOW TO APPLY:
Send your CV directly to firstname.lastname@example.org
Please submit your CV in English.
This is an ongoing search. Short-listed candidates will be contacted accordingly.
PPD Bulgaria EOOD is a registered administrator in accordance with the Bulgarian Law on Protection of Personal Data. All
applications will be treated in strictest confidentiality. PPD Inc. is an equal opportunities employer.