Senior Pv Executive

2 days ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

Global Pharmaceutical MNC
- Strong portfolio of products across multiple therapeutic areas (e.g. Oncology, Immunology, Cardiovascular Disease)
- Risk Management Plans/Risk Minimization Activities

**Main Responsibilities**:
The successful incumbent will be tasked to perform and contribute to pharmacovigilance activities such as individual case safety report and aggregate safety monitoring, AE reporting, risk-benefit assessment, risk management planning and strategy, and execution of post-marketing commitments while ensuring compliance with global regulatory requirements.
- Risk management plans submissions including additional risk minimization materials to relevant health authorities
- Cultivate and maintain PV awarness and performing necessary PV trainings
- Maintenance of local market safety data quality
- Provide safety information and updates on emerging pharmacovigilance or patient safety issues
- Ensure compliance and adherence to Pharmacovigilance Agreements
- Post-marketing adverse events processing including collection, follow-up and submissions to local health authories and ethic committees of post-marketing AE from spontaneous, literature or solicited sources as applicable
- PV audit handling and ensuring inspection readiness

**Requirements**:

- Relevant Bachelor Degree (e.g. life science, pharmacy, nursing)
- At least 2 years' PV experience in the pharmaceutical industry
- Ability to review safety information meticulously and capable of effective problem-solving
- Fluent knowledge in relevant standards and legislations with regards to PV (e.g. ICH, CIOMS)
- Experience with risk management plans and additional risk minimization materials preferred
- Strong organizational, faciliation and interpersonal skills to work cross-functionally with internal and external stakeholders while ensuring adherence to strict deadlines

**Next Steps**:
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

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