Safety & PV Specialist I

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Input data into PVG quality and tracking systems for the receipt and monitoring of ICSR as necessary.

• Aids in the handling of ICSRs in accordance with Standard Operating Procedures (SOPs) and specific project/program safety plans as needed.

• Assesses ICSRs, reviewing ICSR data for thoroughness, precision, and regulatory reporting capability.

• Categorizes events, medical histories, concurrent medications, and tests, while compiling comprehensive narrative summaries.

• Recognizes information that requires clarification and ensures follow-up until the information is acquired and queries are satisfactorily addressed.

• Supports the timely, consistent, and precise reporting of expedited reports in compliance with relevant regulatory obligations.

• Oversees safety tracking for designated activities.

• Conducts literature screening and review for safety, drug coding, and maintenance of the drug dictionary, as well as MedDRA coding as required.

⛳️ Requirements

• A Bachelor’s Degree in life science, nursing, pharmacy, or a comparable mix of education and experience that equips the individual with the necessary knowledge, skills, and abilities to fulfill the role.

• Familiarity with Safety Database systems and medical terminology is essential.

• Strong understanding of the clinical trial process across Phases II-IV and/or post-marketing safety obligations, ICH GCP, GVP, and regulations pertaining to Safety and Pharmacovigilance.

• Competence in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace), and the internet.

• Exceptional communication and interpersonal abilities, both written and verbal.

• Solid organizational skills with a proven track record of prioritizing and managing multiple tasks and projects.

• Detail-oriented with a high level of accuracy and the capability to meet deadlines.

🏝️ Benefits

• We are dedicated to the growth of our employees through career development and advancement; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.