[Hiring] Safety & PV Submission Spec II @Syneos Health Careers

Role Description

Safety & PV Submission Spec II - Experience with safety submissions for clinical trials in LATAM - Brazil Home Based.

Performs safety and pharmacovigilance program delivery activities including (but not limited to):

• Collection, processing, and reporting of individual cases safety reports (ICSRs).
• Literature screening and review for safety.
• Drug coding and maintenance of drug dictionary.
• Medical Dictionary for Regulatory Activities (MedDRA) coding.
• Data management activities including cleaning and validation of data.
• Preparation of expedited and periodic safety reports.
• Adhering to data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, and company procedures.

Responsibilities:

• Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• May assist in the preparation of project plans such as Safety Management Plan.
• May perform set-up, delivery, and close-out of safety and pharmacovigilance projects.
• Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications, and tests.
• Compiles complete narrative summaries.
• Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Coordinates with data management staff concerning reconciliation of safety data between clinical and safety databases.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manual recoding of un-recoded product and substance terms arising from ICSRs.
• Identification and management of duplicate ICSRs.
• Activities related to SPOR / IDMP.
• Quality review of ICSRs and for the work performed by peers.
• Serves as a subject matter expert in SPVG, including resolution of project-related routine queries; mentoring, coaching, and training of new hires.
• Fosters constructive and professional working relationships with all project team members, internal and external.
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
• Participates in audits/inspections as required.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process.

Qualifications

• Bachelor's Degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience.
• Safety Database systems and knowledge of medical terminology required.
• Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP, and regulations related to Safety and Pharmacovigilance.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, email (Outlook), Team Share, and internet.
• Ability to work independently and in a team environment.
• Excellent communication and interpersonal skills, both written and spoken.
• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
• Detail-oriented with a high degree of accuracy and ability to meet deadlines.
• Minimal travel may be required (up to 5%).

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• Commitment to building an inclusive culture where you can authentically be yourself.
• Driven to Deliver - capturing the passion of our colleagues to shape solutions that impact lives.
• Continuous improvement in building the company we all want to work for.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

Over the past 5 years, we have worked with:

• 94% of all Novel FDA Approved Drugs.
• 95% of EMA Authorized Products.
• Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.