Pharmacovigilance Services Associate

Skill required: Pharmacovigilance Operations - Safety Writing

Designation: Pharmacovigilance Services Associate

Qualifications:Master of Pharmacy

Years of Experience:1 to 3 years

What would you do?
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed/interim clinical study reports.

What are we looking for?

Ability to manage multiple stakeholders

Problem-solving skills

Results orientation

Written and verbal communication Roles and Responsibilities:

Support for Clinical Submission Narrative Writing (Narrative Writing) for Phase 1-4 clinical Trials in accordance with client SOP.

Narratives are written based on data listings and/or safety reports (e.g., CIOMS). Safety reports will be provided to Vendor by client.

Provide 100% thorough check of all data points and in accordance with the client SOP and client Style Guide.

Provide finalized narrative which incorporates in-house client MD review comments as well as any Quality Control (QC) findings.

Provide Narrative Table of Contents for each project / study.

Handle and manage studies as a Project LeadQualificationMaster of Pharmacy