Sr. Drug Safety Associate

4-10 years

Not Disclosed

Remote

10 Dec. 30, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Sr. Drug Safety Associate
Job Description:
As a member of our team, the Sr. Drug Safety Associate is expected to actively contribute to a culture of process improvement, focusing on streamlining processes, adding value to our business, and meeting client needs. This role involves working collaboratively with internal teams and sponsors to ensure the accurate and efficient handling of safety-related tasks in compliance with regulatory requirements and company standards.

Key Responsibilities:

Project Activities: Complete all departmental project activities accurately, adhering to ICON SOPs, study-specific procedures, regulatory requirements, and sponsor processes.
Safety Reporting: Review and process serious adverse events, spontaneously reported adverse reactions, and other medically related information as per assigned tasks and study-specific procedures.
Safety Tracking: Provide input and review safety tracking systems for accuracy and quality, assisting with the maintenance of project files.
Project Team Involvement: Attend project team meetings and teleconferences as required.
Safety Resource: Serve as a resource for investigational sites and ICON personnel on safety-related issues.
Training & Mentoring: Assist with training and mentoring newly hired DSA staff as requested.
Scope Management: Help identify out-of-scope activities in collaboration with the MSS Functional Lead.
Procedure Generation: Assist with the generation of study-specific procedures.
Sponsor Liaison: Liaise with the Sponsor and attend Sponsor meetings as needed.
Safety Review: Perform safety reviews of clinical and diagnostic data.
Investigator Liaison: Communicate with investigational sites, reporters, and/or the Sponsor regarding safety issues.
Cross-Departmental Collaboration: Work closely with ICON project managers and other departments.
Leadership: Act as the lead DSA for local or regional projects, under supervision.
Additional Duties: Perform other activities as requested by management.

Key Skills:

Pharmacovigilance
Eudravigilance
Oracle Argus
Aggregate Reporting

Salary: As per company norms
Experience: 4-10 years in Pharma/Biotech/Clinical Research
Industry: Pharma/Biotech/Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: R&D & Training
Employment Type: Permanent, Full Time

Contact Information:
Interested candidates can forward their profile to contact@covalenttrainings.com or reach us for guidance at +91-9848733309 / +91-9676828080.

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Sr. Drug Safety Associate

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