Pharmacovigilance Specialist

1-5 years

Not Disclosed

Bangalore Bengaluru Chennai

10 Aug. 8, 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

About the Role

At ICON, it’s our people that set us apart. Our diverse teams enable us to become better partners to our customers and help us fulfill our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that unify us: Accountability & Delivery, Collaboration, Partnership, and Integrity. We strive to be the Clinical Research Organisation that delivers excellence to our clients and patients at every touchpoint. To be the partner of choice in drug development is our vision, and we need talented people who share this vision.

If you’re as driven as we are, join us. You’ll work in a dynamic and supportive environment with some of the brightest and friendliest people in the sector, helping shape an industry.

Roles & Responsibilities

Ensure accuracy and consistency of safety data processing from receipt to final output (e.g., reports, listings, data export).
Expertise in working with Argus safety database.
Experience working with post-marketing projects, supporting client and company product launches with knowledge of global health authority regulations, especially USFDA, for post-marketing event processing and reporting.
Experience working in clinical trial projects in Argus database.
Conduct and participate in review and quality control of deliverables, ensuring outputs meet expectations and processes described in planning documents.
Review and process serious adverse events, spontaneously reported adverse reactions, and other medically related information per assigned tasks and study-specific procedures.
Review and process literature-based ICSRs identified from articles.
Provide input and review relevant safety tracking systems for accuracy and quality, assisting with maintaining project files.
Perform safety review of clinical and diagnostic data for case processing.
Assist with the generation of regulatory reports to ensure compliance.
Liaise with other ICON departments, investigational sites, reporters, and/or sponsors regarding safety issues.
Support the Pharmacovigilance management team with inputs regarding audits, inspections, and business development activities.
Develop, maintain, and document workflow processes, liaising with external departments as needed.
Provide technical and process oversight for safety services in interdepartmental activities (e.g., listing review, quality control, quality assurance, audits, miscellaneous project activities) and on assigned projects.
Serve as the primary escalation point for internal and external team members for risks associated with assigned services.
Complete first-line reviews of complex planning documents for contracted services (e.g., Safety Management Plans, SAE Reconciliation Plans, Literature Search Plans) ensuring consistency across assigned projects and service areas.
Serve as Functional Lead on case processing or medical information projects, coordinating teams of Pharmacovigilance associates and acting as the point of contact for project teams.
Maintain the safety database and corresponding entry guidelines, ensuring data quality through established quality control processes.
Generate data listings from the safety database, ensuring accuracy.
Support analysis and quality control during the generation of Aggregated Safety Reports (e.g., Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports).
Support Safety Scientists in signal detection and risk management activities.
Support interim data analysis for DMC reviews.
Participate in internal and client project team meetings, presenting the safety process at kick-off and investigator meetings.
Ensure timely completion of internal and external status reporting, metrics, and key performance indicators for assigned services.
Identify and escalate operational and/or financial risks related to assigned services.
Support the department management team in developing training courses, SOPs, and associated documents.
Conduct safety training sessions for assigned team members and serve as a lead mentor for less experienced staff.
Propose solutions for procedural and technical issues.
Support audits and inspections for assigned service areas and/or projects.
Perform other activities as identified and requested by management, including responding to and processing medical information inquiries related to adverse events/reactions and product complaints for Clients’ product(s).
Review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals, maintaining medical understanding of applicable therapeutic areas and disease states.
Support business development activities by reviewing the safety section of proposals and attending sponsor bid defense meetings.
Involved in creating and revising Pharmacovigilance-related manuals and process documents.
Act as Subject Matter Expert in departmental initiatives.

For ICON Strategic Solutions:

Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, partners, and ICON personnel within project-specified timelines.
Support PV processing management in all aspects of departmental activities, including quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight, and CAPA oversight as designated.
Work within multiple databases, maintaining project information with timely updates.
Perform filing and quality control of documents submitted to the eTMF or agreed filing solution, ensuring file readiness for audits or inspections.
Perform or supervise periodic reconciliation of adverse event and/or quality complaint cases within required deadlines.
Submit safety reports to licensing partners of ICON clients.
Code Adverse Events according to the applicable standard dictionary.
Perform or supervise quality complaint activities for assigned projects.
Perform quality control of activities as applicable.
Maintain a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents, and manuals associated with case processing.
Provide technical and process oversight with respect to safety case processing services on assignments.
Perform oversight of assigned projects or portfolio, ensuring all ICON, Sponsor, and regulatory timeframes are met for reporting safety information.
Operate in a lead capacity, ensuring ownership and accountability of case processing activities on assigned projects.

At ICON, we are committed to providing equal employment opportunities for all individuals. We adhere to all applicable laws and regulations governing non-discrimination in employment practices.

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