Pharmacovigilance Associate – Safety Case Processing

MNC JOBS INFO; Singapore; Hybrid; SGD 42,000 - 68,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Hybrid working

Professional development

Job summary

MNC JOBS INFO is seeking a Pharmacovigilance Associate to support safety case processing, adverse event reporting, and regulatory compliance. The role involves receiving, reviewing, and entering ICSRs, ensuring data accuracy, and maintaining documentation in pharmacovigilance databases.

You'll collaborate with drug safety, regulatory affairs, and clinical teams to uphold patient safety, quality standards, and timelines across on-site, hybrid, or remote work arrangements where applicable.

Qualifications

• Bachelor's degree in Pharmacy or Life Sciences preferred.
• Additional pharmacovigilance training or certification is an advantage.
• Familiarity with ICSR intake, MedDRA coding, and safety databases is expected.

Responsibilities

• Receive, review and process ICSRs according to SOPs and regulatory guidelines.
• Enter demographics, events and product data into safety databases with accuracy.
• Perform quality checks and escalate safety concerns as needed.
• Support regulatory reporting timelines and document management.

Skills

Attention to detail

English communication

Time management

Analytical thinking

Independent work

Education

Bachelor's degree in Pharmacy or Life Sciences

Pharmacovigilance certification (advantage)

Tools

MedDRA coding

Pharmacovigilance databases

Microsoft Office

Job description

1. Job Summary

MNC JOBS INFO is seeking a detail-oriented and quality-focused Pharmacovigilance Associate – Safety Case Processing to support drug safety monitoring, adverse event reporting, and pharmacovigilance operations. This role is suitable for professionals interested in pharmaceutical safety, clinical research, regulatory compliance, and patient protection.

The successful candidate will be responsible for receiving, reviewing, processing, documenting, and tracking Individual Case Safety Reports (ICSRs) associated with pharmaceutical products, vaccines, medical treatments, and other healthcare products. The role involves evaluating incoming safety information, entering accurate data into pharmacovigilance databases, identifying missing information, and ensuring that safety cases are handled in accordance with applicable regulatory requirements and established standard operating procedures (SOPs).

The Pharmacovigilance Associate will collaborate with drug safety teams, medical reviewers, regulatory affairs professionals, clinical research teams, and other relevant stakeholders to maintain high standards of data accuracy, documentation, and reporting compliance.

This position offers an opportunity to develop specialized expertise in pharmacovigilance, adverse event reporting, regulatory submissions, and pharmaceutical safety management while contributing to the protection of patients and public health.

2. Key Responsibilities

Safety Case Intake and Processing

• Receive and review adverse event reports from healthcare professionals, patients, clinical investigators, pharmaceutical partners, and other authorized sources.
• Register incoming safety cases and verify that essential information is available for case processing.
• Process Individual Case Safety Reports (ICSRs) according to established company procedures, project requirements, and applicable regulatory guidelines.
• Identify the minimum information required for a valid safety case, including an identifiable patient, an identifiable reporter, a suspected medicinal product, and a suspected adverse reaction or event.
• Classify cases appropriately, including serious and non-serious adverse events, where applicable.

Data Entry and Medical Information Documentation

• Enter patient demographics, medical history, suspected products, adverse events, concomitant medications, and relevant clinical details into designated safety databases.
• Ensure that case narratives accurately reflect the information provided in source documents.
• Review case information for completeness, consistency, accuracy, and clarity.
• Apply appropriate medical terminology and coding conventions, including MedDRA for adverse events and relevant drug dictionaries for medicinal products, as required.
• Maintain traceable documentation of case updates, corrections, and follow-up activities.

Case Assessment and Quality Control

• Review incoming reports to identify duplicate cases, missing information, inconsistencies, and potential data discrepancies.
• Support seriousness, expectedness, and causality assessments in accordance with approved procedures and assigned responsibilities.
• Escalate potential serious adverse reactions, special situations, and other safety concerns to the appropriate medical or safety personnel.
• Perform quality checks before case submission or completion.
• Address quality review findings and implement corrective actions to reduce recurring processing errors.

Follow-Up and Information Management

• Assist with obtaining additional information from reporters, healthcare professionals, clinical sites, or other authorized sources.
• Track outstanding follow-up requests and maintain accurate records of responses.
• Update safety databases when new medical information becomes available.
• Ensure that case documentation is organized, complete, and readily available for authorized review.

Regulatory Compliance and Reporting Support

• Support the preparation and processing of safety reports within applicable regulatory reporting timelines.
• Follow pharmacovigilance regulations, internal SOPs, work instructions, and project-specific requirements.
• Help maintain audit-ready records and support internal audits, regulatory inspections, and quality assessments.
• Protect confidential patient information and comply with applicable data privacy requirements.
• Inform the appropriate team members about urgent cases, reporting deadline risks, and potential compliance issues.

Team Collaboration and Continuous Improvement

• Work with pharmacovigilance specialists, medical reviewers, quality assurance teams, and regulatory affairs personnel to resolve case-related issues.
• Participate in team meetings, training sessions, process reviews, and quality improvement initiatives.
• Meet established productivity, accuracy, and turnaround-time targets.
• Stay informed about relevant pharmacovigilance guidelines, medical terminology, and safety case processing practices.

3. Required Skills and Qualifications

Educational Qualifications

• A bachelors degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Nursing, Biotechnology, Medicine, or a related healthcare discipline is preferred.
• A B.Pharm, M.Pharm, Pharm.D, B.Sc. in Life Sciences, M.Sc. in a relevant discipline, or an equivalent qualification may be suitable, depending on project requirements.
• Additional training or certification in pharmacovigilance, clinical research, drug safety, or regulatory affairs is an advantage.

Technical Skills

• Basic understanding of pharmacovigilance principles and adverse event reporting.
• Familiarity with Individual Case Safety Reports (ICSRs) and the safety case lifecycle.
• Knowledge of serious and non-serious adverse events, seriousness criteria, and safety reporting concepts.
• Familiarity with MedDRA coding, drug dictionaries, and pharmacovigilance databases is desirable.
• Basic understanding of ICH guidelines, Good Pharmacovigilance Practices (GVP), and relevant regulatory requirements.
• Proficiency in Microsoft Word, Excel, Outlook, and other standard office applications.
• Ability to work with electronic databases, document management systems, and structured data entry tools.

Professional Skills

• Excellent attention to detail and strong data accuracy.
• Good written and verbal communication skills in English.
• Strong organizational and time-management abilities.
• Analytical thinking and problem-solving skills.
• Ability to interpret medical information and identify inconsistencies.
• Willingness to follow documented procedures and maintain confidentiality.
• Ability to work independently while contributing effectively to a team.
• Flexibility to learn new safety systems, processes, and regulatory requirements.

4. Experience

The experience requirements will depend on the seniority of the position and the needs of the assigned project.

Entry-Level Candidates

• Fresh graduates with relevant healthcare, pharmacy, or life sciences qualifications may be considered for suitable trainee or junior associate positions.
• A basic understanding of medical terminology, drug safety, and adverse event reporting is beneficial.
• Candidates should demonstrate strong attention to detail, willingness to learn, and the ability to follow established procedures.

Experienced Candidates

• Approximately 1–3 years of experience in pharmacovigilance, safety case processing, clinical research, medical information, or a related pharmaceutical function is preferred for experienced associate roles.
• Practical experience with ICSR intake, data entry, medical coding, case narrative writing, follow-up activities, and quality review is advantageous.
• Experience with pharmacovigilance databases and regulatory reporting workflows is desirable.
• Candidates with relevant qualifications, strong documentation skills, and a commitment to patient safety are encouraged to apply for positions that match their experience level.

5. Working Hours

• Employment Type: Full-time, subject to the specific vacancy.
• Work Arrangement: On-site, hybrid, or remote, depending on the position and employer requirements.
• Typical Schedule: Approximately 8–9 hours per working day, including applicable breaks.
• Shift Requirements: Day, evening, night, or rotational shifts may be required for global pharmacovigilance operations.
• Weekend Work: Occasional weekend or holiday coverage may be necessary to support time-sensitive safety reporting activities.
• Flexibility: Employees should be prepared to coordinate with international teams across different time zones when required.
• Actual working hours, shift patterns, employment arrangements, and availability of remote work will be confirmed during the recruitment process.

6. Knowledge, Skills, and Abilities

Pharmacovigilance Knowledge

• Understanding of the purpose and importance of pharmacovigilance in identifying, assessing, and preventing adverse effects associated with medicinal products.
• Knowledge of the basic safety case lifecycle, from initial receipt through validation, processing, quality review, and submission where applicable.
• Awareness of case validity criteria, seriousness assessment, expectedness, causality, and follow-up requirements.
• Familiarity with ICH E2A and ICH E2B concepts is beneficial.
• Awareness of relevant local and international pharmacovigilance regulations and reporting requirements.

Data Management and Documentation

• Ability to accurately capture, organize, and maintain safety information.
• Capacity to review source documents and prepare clear, objective case narratives.
• Ability to identify incomplete records, inconsistencies, and possible duplicate reports.
• Understanding of the importance of data integrity, audit trails, and controlled documentation.

Communication and Collaboration

• Ability to communicate case-related questions and processing issues clearly.
• Confidence in coordinating with internal teams and authorized external contacts.
• Ability to document work in a professional, factual, and traceable manner.
• Willingness to receive feedback and participate in ongoing training.

Personal Attributes

• Strong sense of responsibility and commitment to patient safety.
• Consistent attention to detail when handling complex medical information.
• Ability to prioritize tasks according to urgency and reporting deadlines.
• Professional integrity when handling confidential data.
• Adaptability in a changing regulatory and pharmaceutical environment.

7. Benefits

• Competitive salary based on qualifications, experience, location, and role responsibilities.
• Structured onboarding and training in pharmacovigilance procedures and safety case processing.
• Opportunities to develop knowledge of drug safety databases and medical coding systems.
• Professional development through internal training, quality workshops, and regulatory learning sessions.
• Exposure to pharmaceutical safety operations and international healthcare projects.
• Opportunities to progress into senior pharmacovigilance, quality assurance, medical review support, or regulatory affairs roles.
• Potential access to health insurance, paid leave, retirement benefits, and other employment benefits where applicable.
• Flexible or hybrid working arrangements where supported by the specific employer and project.
• A collaborative environment focused on data quality, regulatory compliance, and patient safety.
• The availability of each benefit will be confirmed in the official vacancy details and employment offer.

8. Why Join MNC JOBS INFO?

Joining a pharmacovigilance team through a vacancy advertised by MNC JOBS INFO can be an opportunity to pursue a career in the pharmaceutical and healthcare safety sector.

Build Specialized Expertise: Develop practical knowledge of adverse event reporting, safety case documentation, medical terminology, and pharmacovigilance workflows.

Contribute to Patient Safety: Support the accurate handling of information that helps healthcare organizations monitor the safety of medicinal products and identify potential risks.

Develop Your Career: Build a foundation for future opportunities in pharmacovigilance operations, safety database management, quality assurance, regulatory affairs, and related healthcare functions.

Strengthen Your Professional Skills: Improve your data management, analytical thinking, documentation, and regulatory compliance capabilities.

Work in a Quality-Focused Environment: Learn the importance of accuracy, traceability, confidentiality, and adherence to established procedures.

Gain Exposure to Global Standards: Depending on the assigned role, gain experience with international safety reporting practices and collaboration across healthcare and pharmaceutical teams.

MNC JOBS INFO is presented here as the organization advertising the opportunity. The specific employing company, work location, compensation, and employment benefits should be verified in the official vacancy announcement before accepting an offer.