Patient Safety Specialist
3 weeks ago
Exciting opportunity alert A leading global pharmaceutical company at the forefront of scientific research, dedicated to addressing critical medical needs, is on the lookout for a Patient Safety Specialist to join their dynamic team.
In this role, you'll be pivotal in driving pharmacovigilance activities, encompassing individual case safety report handling, aggregate safety monitoring, adverse event reporting, risk-benefit assessment, and the development and execution of risk management plansâ€'all while ensuring strict compliance with global regulatory standards.
Key Responsibilities:- Expertly handle PV audits and maintain readiness for inspections.
- Foster and sustain awareness of pharmacovigilance practices through tailored training initiatives.
- Uphold the quality of safety data in local markets.
- Disseminate safety updates and insights on emerging pharmacovigilance trends or patient safety concerns.
- Ensure adherence to Pharmacovigilance Agreements.
- Lead the submission of risk management plans, including crafting additional risk minimization materials for relevant health authorities.
- Manage the processing of post-marketing adverse events, including thorough data collection, follow-up procedures, and submissions to local health authorities and ethics committees.
- Relevant Bachelor Degree (e.g. life science, pharmacy, nursing)
- At least 1-2 years' experience in the pharmaceutical industry.
- Experience in pharmacovigilance and/or regulatory affairs is highly advantageous.
- Strong organizational, faciliation and interpersonal skills.
Interested applicants may apply directly with your most recent CV in word format and we shall get in touch shortly for a confidential discussion on this exciting opportunity.
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
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