Senior Pharmacovigilance

OrciMed Life Sciences Philippines OPC; Metro Manila; Remote; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Work from home

Equipment provided

Job summary

OrciMed Life Sciences Philippines OPC seeks a Senior Pharmacovigilance specialist to manage safety cases from clinical trials, ensuring accurate documentation, evaluation, and reporting of adverse events in line with global PV regulations.

The role requires 3+ years of PV/Drug Safety experience, a life sciences-related degree, and willingness to work night shifts. 100% work-from-home setup is provided, with residency in Metro Manila or nearby areas.

Qualifications

• 3+ years' experience in Pharmacovigilance/Drug Safety
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing or related field preferred
• Willing to work night shift
• Residing within Metro Manila / neighboring cities

Responsibilities

• Handle case intake, triage, and data entry of adverse events, SAEs, and SUSARs from clinical sources
• Process safety cases per regulatory guidelines, protocols, and SOPs
• Review source documents including CIOMS forms, MedWatch forms, investigator communications
• Conduct medical review and perform causality and expectedness assessments
• Follow up with investigators to obtain missing information and ensure data completeness
• Manage safety queries and resolve case discrepancies promptly
• Prepare and submit expedited safety reports to regulators, ethics committees, and investigators within timelines
• Maintain accurate documentation and adherence to global PV standards

Skills

PV Case Processing

Adverse Event Reporting

SUSAR Reporting

Regulatory Compliance

CIOMS/MedWatch Review

Attention to Detail

Education

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field

Tools

Argus Safety

ARISg

PV Edge

Veeva Vault Safety/EDC

Job description

The Senior Pharmacovigilance is responsible for the intake, processing, and management of safety cases arising from clinical trials. This role focuses on accurate documentation, evaluation, and reporting of adverse events in compliance with global pharmacovigilance regulations, study protocols, and company procedures.

Essential Functions:

• Perform case intake, triage, and data entry of adverse events, serious adverse events, and SUSARs from clinical trial sources


• Process safety cases in accordance with regulatory guidelines, study protocols, and internal standard operating procedures


• Review and interpret source documents including CIOMS forms, MedWatch reports, investigator communications, and clinical trial documentation


• Conduct medical review of cases and perform causality and expectedness assessments based on investigator reports and protocol requirements


• Perform case follow up with investigators or study teams to obtain missing information and ensure data completeness


• Manage safety queries and ensure timely resolution of case discrepancies


• Prepare and submit expedited safety reports to regulatory authorities, ethics committees, and investigators within required timelines


• Maintain accurate documentation and ensure compliance with global pharmacovigilance standards and reporting regulations

Knowledge, Skills, and Abilities:

• Experience in pharmacovigilance case processing within clinical trials


• Strong understanding of adverse event reporting, serious adverse events, and SUSAR reporting requirements


• Familiarity with global safety reporting regulations and clinical trial safety procedures


• Experience reviewing clinical safety documentation such as CIOMS and MedWatch forms


• Strong attention to detail and ability to meet strict regulatory timelines

Safety Database Experience:

• Argus Safety


• ARISg


• PV Edge


• Preferred experience with Veeva Vault Safety and EDC databases

Must have

• Minimum of 3 years' experience as Pharmacovigilance / Drug Safety Specialist


• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field preferred.

Must be willing to work night shift

Must be residing within Metro Manila / neighboring cities

100% Work from Home Setup

Equipment is provided