Safety Expert

1 day ago

Province of Palawan, Mimaropa, Philippines beBeePharmacovigilance Full time ₱600,000 - ₱900,000
Pharmaceutical Safety Specialist

We are seeking a highly skilled Pharmaceutical Safety Specialist to join our team. The ideal candidate will have experience in pharmacovigilance, regulatory requirements, and case management.

Key Responsibilities:
  • Data entry of vigilance cases into relevant databases according to established conventions.
  • Quality control of vigilance cases and associated documents to ensure accuracy and compliance with regulatory requirements.
  • Medical review of vigilance cases to identify potential safety signals and perform causality assessments.
  • Follow-up on vigilance cases via phone or mail to ensure timely resolution.
  • Pre-analysis of complex cases to optimize data entry and minimize errors.
  • Identification of submission requirements for safety cases to ensure seamless communication with stakeholders.
  • Review and analysis of ICSRs downloaded from competent authorities' databases to stay up-to-date on emerging trends and safety concerns.
  • Performing reconciliations of partner, medical information, and quality complaint data to maintain accurate records.
  • Participation in the operational implementation of new projects to drive business growth and improvement.
  • Key contact for projects, collaborating with team leaders, activity managers, and project managers to achieve project goals.
Required Skills and Qualifications:
  • Pharmacist or Life Sciences degree with more than 3 years of experience in pharmacovigilance.
  • Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
  • Excellent client communication skills and ability to work to deadlines.
Benefits:

This is an exciting opportunity to join a dynamic team and contribute to the advancement of pharmaceutical safety. Our company offers a collaborative work environment, opportunities for professional growth, and a competitive compensation package.

Other Requirements:

A successful Pharmaceutical Safety Specialist will possess a strong passion for pharmacovigilance, excellent analytical skills, and the ability to work independently with minimal supervision. If you are a motivated individual looking to make a meaningful impact in the pharmaceutical industry, we encourage you to apply for this challenging role.

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