job title: Safety and pharmacovigilance trainee (syneos)

Roles and Responsibilities

Monitors and routes incoming information to the appropriate project if required.

• Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes if required.

• Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP if required.

• May enter data or assist in the creation of cases into the safety database in accordance with Sponsor/customer specific guidelines and Company standards if required.

• Ensures current conventions are followed when entering cases into the Safety database.

• May perform file creation, tracking, retention, and maintenance (paper and electronic).

• Manages the translation process for any source documents requiring translation if required.

• Performs or assist with query follow up process as instructed.

• Assists with submission processes as required.

• May assist with daily workflow reconciliation.

• Assists with global or local safety literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding, if required.

• May assist with narrative writing.

• May assist with coding events, medical history, concomitant medications, and tests.

• May assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.

• Validation of xEVMPD product records, including appropriate coding of indication terms using MedDRA, if required.

• Manual recoding of un-recoded product and substance terms arising from ICSRs if required.

• Identification and management of duplicate ICSRs if required.

• Activities related to SPOR / IDMP if 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 of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.

• Fosters constructive and professional working relationships with all project team members, internal and external.

• Participates in audits as required/appropriate.

• Applies safety reporting regulatory intelligence maintained by Syneos Health, or our customers, to all safety reporting activities, if required.

Qualification Requirements -

Education & Eligibility (Required):

• M.Pharm, Pharm.D, M.Sc + B.Pharm. , BHMS, BDS or Ph.D. (Pharmacy) passed out in the year 2025.

• Candidates with the above healthcare educational backgrounds passed out in the year 2024, who have a strong interest in Pharmacovigilance may only apply.

Core Skills (Required):

• Strong knowledge and interest in a healthcare/scientific background is a must.

• Proficiency in Microsoft Office Suite and Outlook.

• Strong organizational, documentation, and multitasking skills.

• Excellent written and verbal communication.

• Ability to collaborate effectively in a team environment.

• High attention to detail and accuracy.

Preferred Qualifications:

• Familiarity with safety databases, medical terminology, pharmacology, or pharmacovigilance.

• Experience with collaboration tools (Visio, Team Share, or equivalent).