Clinician (Pharmacovigilance)

Wipro Ltd.; Philippines; On-site; PHP 600,000 - 1,200,000; Full time

Job summary

Wipro Limited in Quezon City, Philippines, is seeking a Clinician for Pharmacovigilance to lead medical safety input, risk assessment, and post‑market surveillance activities. The role collaborates with the Medical Safety Officer and cross‑functional teams to ensure robust safety processes and regulatory compliance.

The ideal candidate has 3–5 years in pharmacovigilance or clinical research, strong analytical skills, and familiarity with FDA or regulatory reporting.

Qualifications

• Bachelor’s degree in an allied health field with licenses.
• 3–5 years in clinical research, pharmacovigilance, or related fields.
• 3–5 years in pharma/medical device industry or clinical experience preferred.
• Regulatory affairs or QA or complaint handling experience preferred.
• Understanding of risk assessment principles preferred.
• Experience interacting with FDA or other regulatory agencies preferred.
• Excellent communications and analytical skills.
• Proficiency with Microsoft Office (Excel, PowerPoint, Access).

Responsibilities

• Collaborate with Medical Safety Officer to ensure medical review input for safety reports and surveillance plans.
• Contribute to risk management, post-market surveillance, and regulatory filings.
• Assist in health hazard evaluations and data review for safety signals and escalation.
• Support development teams with clinical input for risk management documents (FMEA, RMS, PSR).
• Guide complaint handling investigations and ensure proper regulatory reporting of events.

Skills

Communication skills

Analytical skills

Regulatory affairs

Pharmacovigilance knowledge

Education

Bachelor's degree in Allied Health

Tools

Microsoft Office

Job description

Clinician (Pharmacovigilance)

Company : Wipro Job Type : Full Time Quezon City, Philippines

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Job Description - Clinician (Pharmacovigilance)

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. Leveraging our holistic portfolio of capabilities in consulting, design, engineering, and operations, we help clients realize their boldest ambitions and build future-ready, sustainable businesses. With over 230,000 employees and business partners across 65 countries, we deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world. For additional information, visit us at www.wipro.com.

Responsibilities:

• Ensures, in collaboration with the Medical Safety Officer, processes are in place to guarantee appropriate medical review and input to:
• Risk management report, Safety Surveillance Plans, Post-market surveillance reports, Response to Adverse Event (AE), complaints and mass communications
• Internal and customer safety training materials
• Complaint handling process and reporting decisions. R egulatory reports and filings of p roduct’s harms and hazards list
• Coordinates activities related to trending and escalation in collaboration with the Quality Unit and the Medical safety Officer:
• Coordinates completions of the Health Hazard Evaluation including routing documents to MSO, review of appropriateness of data available, tracking of timeliness and routing for approval.
• Review of periodic surveillance data to identify any significant triggers and provide an analysis of the triggered events to identify any safety concerns.Participate in periodic trending meeting and provide input on actions taken for identified signals.
• Complete Analysis of identified trends and make recommendations for further escalation when appropriate.
• Coordinate completion of Health Risk Assessment for Product Issue Escalation and participate, in collaboration with the Medical Safety Officer, in multidisciplinary team discussions by providing surveillance data analysis and severity assessment per risk management documentation.
• Coordinates and completes activities related to Product development and risk management in collaboration with New Product Development teams and the MSO:
• Represent Medical Safety interests in multi-disciplinary teams during product development.
• Perform clinical reviews and provide input of clinically related product risk issues during the development of the clinical portion of risk management documents such as FMEA’s, Risk Management Plan, Risk Management Report and Post-market Surveillance reports in support of new product development and regulatory requirements.
• Evaluation and review of non-Clinical contributions to risk management documents such as FMEA’s, Risk Management Plans, Risk Management Reports, Post-market Surveillance reports and Health Hazard Evaluations for conformance to procedure, completeness, content and accuracy.
• Coordinates and completes activities related to support of the Complaint Handling process in collaboration with the Complaint Handling Unit and the MSO:
• Provide guidance to complaint handling specialist regarding investigation of product related events reported worldwide from patients, customers, sales reps and clinical studies/registries in order to assess product relationship to reported complaint.
• Provide clinical guidance and validates correct coding and regulatory reporting of complaint files.

Qualifications:

• Bachelor's Degree graduate of any Allied Health Professionals with licenses.
• At least 3 to 5 years of experience in clinical research, pharmacovigilance, and surgical background and/or equivalent is required.
• At least to 3 to 5 years of experience in the pharmaceutical, medical device industry or direct device clinical experience preferred.
• Regulatory Affairs/ Quality Assurance or complaint handling experience in pharmaceuticals or medical devices preferred.
• Understanding of risk assessment principles preferred
• Experience interacting with the FDA and/or other regulatory agencies preferred
• Excellent communications and analytical skills
• Working knowledge of Microsoft Office, Excel, Power Point, Access

Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma)

Experience: 5-8 Years

Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention.