Senior Pharmacovigilance Case Manager Remote Night Shift

OrciMed Life Sciences Philippines OPC

Metro Manila

Remote

PHP 600,000 - 900,000

Full time

9 days ago
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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

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.

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