Senior Pharmacovigilance Specialist (Remote)

OrciMed Life Sciences Philippines OPC

Metro Manila

Remote

PHP 900,000 - 1,300,000

Full time

3 days ago
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Job summary

OrciMed Life Sciences Philippines OPC is seeking a highly detail-oriented Senior Drug Safety Specialist to join the Pharmacovigilance team. The successful candidate will manage intake, processing, evaluation, and reporting of safety cases arising from clinical trials while ensuring compliance with global pharmacovigilance regulations and internal procedures.

This role requires hands-on experience in clinical trial case processing, expedited safety reporting, and regulatory submissions.

Qualifications

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

Responsibilities

  • Handle intake, processing, evaluation, and reporting of safety cases from clinical trials.
  • Prepare, review, and submit safety reports to regulatory authorities and ethics committees, including expedited and periodic submissions.
  • Ensure compliance with global pharmacovigilance regulations, study protocols and internal procedures.
  • Maintain ability to meet strict regulatory timelines and communicate effectively in writing and verbally.

Skills

AE reporting
SAE reporting
SUSAR reporting
Regulatory timelines
Attention to detail
Written communication
Verbal communication
Clinical trial pharmacovigilance
Pharmacovigilance experience

Education

Bachelor's degree in Pharmacy, Nursing, Life Sciences

Tools

Argus Safety
ARISg
PV Edge
Veeva Vault Safety
EDC Databases

Job description

OrciMed Life Sciences Philippines OPC is seeking a highly detail-oriented Senior Drug Safety Specialist to join the Pharmacovigilance team. The successful candidate will manage intake, processing, evaluation, and reporting of safety cases arising from clinical trials while ensuring compliance with global pharmacovigilance regulations and internal procedures.

This role requires hands-on experience in clinical trial case processing, expedited safety reporting, and regulatory submissions.

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