Safety & Pv Specialist Ii

hace 2 semanas

Tláhuac, Ciudad de México Syneos - Clinical and Corporate - Prod A tiempo completo

Description

Safety & Pharmacovigilance Specialist II
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.


Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are 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.
  • We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we're able to create a place where everyone feels like they belong.

Job responsibilities

  • Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required.
  • May assist in the preparation of the project plans such as Safety Management Plan.
  • May perform setup, delivery and closeout of safety and pharmacovigilance projects.
  • Processes ICSRs according to Standard Operating Procedures (SOPs) and project/programspecific safety plans.
  • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
  • 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 the 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 unrecoded product and substance terms arises from ICSRs.
  • Identification and management of duplicate ICSRs.
  • Activities related to SPOR / IDMP.
  • Quality review of ICSRs.
  • Quality review for the work performed by peers.
  • 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 postmarketing projects to the Safety Submissions team if contracted to submit the reports.
  • Participate 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 postmarketing 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

What we're looking for

  • Bachelor's Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
  • Safety Database systems and knowledge of medical terminology required.
  • Good understanding of clinical trial process across Phases II-IV and/or postmarketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
  • 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 degre

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