Job Title: PV Associate/Sr PV Associate
Location: Chennai
Job Code: JR127208
Department: Drug Safety
Company: ICON plc (Full Service & Corporate Support Office Based)
Job Overview:
ICON plc is a leading healthcare intelligence and clinical research organization, dedicated to shaping the future of clinical development. They are seeking a Pharmacovigilance (PV) Associate/Sr PV Associate to support pharmacovigilance activities for both pre-marketing and post-marketing drug safety processes.
Key Responsibilities:
Review and process safety events (adverse events) for various product stages (pre-marketing, post-marketing, medical device).
Conduct safety literature reviews to identify safety information from scientific abstracts and full articles.
Maintain safety database and ensure accuracy of data listings.
Perform adverse event follow-ups, communicate with reporters, investigational sites, and sponsors.
Develop and review safety management plans and safety tracking systems.
Generate and support the creation of safety reports and regulatory submissions (e.g., PSMF, RMP, PBRER).
Perform signal detection and risk management activities.
Support the Qualified Person for Pharmacovigilance (QP) and assist in audits and inspections.
Attend project team and sponsor meetings, providing input on safety processes.
What You Will Be Doing:
Collect and review adverse event reports in compliance with regulatory guidelines.
Collaborate with cross-functional teams to support safety investigations.
Stay updated on pharmacovigilance regulations and best practices.
Assist in preparing safety reports for regulatory submissions.
Required Qualifications:
Education: Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred.
Experience: Experience in pharmacovigilance, drug safety, or clinical/pharmaceutical environment.
Skills: Strong analytical skills, attention to detail, excellent communication, and interpersonal skills.
What ICON Offers:
Competitive salary with benefits including health insurance, retirement plans, and wellness programs.
Global Employee Assistance Program offering 24/7 support.
Flexible and family-friendly benefits, such as annual leave and childcare vouchers.
Company Culture & Values:
ICON fosters an inclusive and diverse culture.
Commitment to providing an accessible and discrimination-free workplace.
Equal consideration for all qualified applicants, regardless of background.
How to Apply:
Interested candidates are encouraged to apply, even if they don’t meet all the listed requirements. ICON is open to a diverse range of candidates for this and other roles.
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