IQVIA is hiring a Safety Aggregate Report Specialist 2 (exclusively in Kolkata).
Work Type: Full-Time
Workplace Duties:
Work Summary: IQVIA is seeking a Safety Aggregate Report Specialist to work in Kolkata, India. Managing safety aggregate reports, literature surveillance, signal management operations, and benefit risk management paperwork are among your responsibilities in this position.
Crucial Roles:
- Assume responsibility for the SARA deliverables and make sure that service level agreements (SLAs) are followed.
- Oversee the creation and completion of numerous aggregate reports, such as line listings, RMPs, DSURs, PADERs, PBRERs/PSUR, and RMPs.
- When necessary, draft answers to questions from the Pharmacovigilance Risk Assessment Committee (PRAC) and regulatory bodies.
- Maintain continuous literature safety surveillance, including identification of ICSRs and aggregate data review, for both marketed and investigational products.
- Assume the role of Signal Management Lead for post-marketing and clinical trial initiatives, establishing signaling protocols, carrying out signal identification tasks, and recording signals.
- Interface with clients and collaborate with internal functional groups within Lifecycle Safety and other business units.
- Take part in audits, support departmental objectives, and follow standard operating procedures (SOPs).
Qualifications:
- Requires a bachelor's degree in a medical or scientific field.
- Preferably two to three years of relevant work experience.
- outstanding familiarity with Lifecycle Safety services and procedures combined with a readiness to pick up new abilities.
- Understanding of global regulatory requirements such as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines.
- Proven ability to meet deadlines, manage competing priorities, and maintain high-quality standards.
Proficiency in Microsoft Office applications and familiarity with medical terminology.
- Strong communication, organizational, and time management skills.
- good judgment, self-reliance, and ability to make decisions.
- Self-driven, adaptable, and possessing strong coaching and mentoring abilities.
- strong project management, operational metrics, and leadership skills knowledge.
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IQVIA Jobs; PV Safety Aggregate Report Specialist 1[/caption]
About IQVIA: IQVIA is a world leader in clinical research services, technology solutions, and advanced analytics for the life sciences sector. Come along with us to positively influence healthcare around the world. Visit IQVIA Careers to learn more.
How to Apply:
Don't miss this opportunity to contribute to impactful work and grow your career at IQVIA. Apply now for the IQVIA Hiring Safety Aggregate Report Specialist 2 - Kolkata using the
IQVIA PV Referral Link.
https://pharmastuff.org.in/job/iqvia-hiring-safety-aggregate-report-specialist-kolkata?feed_id=3965
