Pv Associate/Sr Pv Associate

0-5 years

Not Disclosed

Remote

10 Oct. 21, 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

Pharmacovigilance Associate - Chennai, India

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are proud to cultivate an inclusive environment that drives innovation and excellence, and we invite you to join us in shaping the future of clinical development.

What You Will Be Doing:

Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs) according to assigned tasks and project-specific procedures.
Analyze abstracts and full articles to extract safety information from literature for both pre- and post-marketed products.
Generate data listings from the safety database, ensuring data accuracy.
Conduct adverse event follow-ups through written communication and phone calls as per client requirements.
Review safety tracking systems for accuracy and quality, assisting with project file maintenance.
Perform safety reviews of clinical and diagnostic data as part of case processing.
Develop and maintain the Safety Management Plan, ensuring consistency within the project.
Support post-marketing safety activities, including PSMF, RMP, and PBRER.
Liaise with investigational sites, reporters, and sponsors regarding safety issues.
Collaborate with ICON Medical Monitors, project managers, and other departments as necessary.
Identify out-of-scope activities alongside the Pharmacovigilance Project lead.
Attend project team and sponsor meetings, presenting safety processes as needed.
Assist in generating Aggregated Safety Reports (e.g., Development Safety Update Report, IND Annual Report).
Support interim data analysis for DMC reviews.
Maintain the safety database and ensure data quality following established processes.
Assist in creating the SAE/AE reconciliation plan and support SAE reconciliation.
Support Safety Scientists in signal detection and risk management activities.
Propose solutions for procedural and technical issues.
Support audits and inspections for assigned projects.
Respond to and process medical information inquiries related to adverse events and product complaints.

Your Profile:

Experience in a Pharmaceutical/CRO environment.
At least 1 year of experience in pharmacovigilance.
Excellent verbal and written communication skills.
Detail-oriented with fluency in written and verbal English.
Strong organizational and time management skills.
Ability to work independently and collaboratively within a global team.

What ICON Can Offer You:

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, ICON offers a range of benefits designed to promote well-being and work-life balance for you and your family, including:

Various annual leave entitlements
Comprehensive health insurance options
Competitive retirement planning offerings
Global Employee Assistance Programme, providing 24-hour access to support
Life assurance
Flexible country-specific optional benefits, such as childcare vouchers and discounted gym memberships

Visit our careers site to learn more about the benefits ICON offers.

ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you need reasonable accommodations during the application process, please let us know or submit a request here.

Interested in the role but unsure if you meet all the requirements? We encourage you to apply anyway—there’s a good chance you’re exactly what we’re looking for at ICON, whether for this role or others.

Are you a current ICON Employee? Click here to apply.

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Pv Associate/Sr Pv Associate

Job Description

Pharmacovigilance Associate - Chennai, India

What You Will Be Doing:

Your Profile:

What ICON Can Offer You:

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