Executive Search Firm Monroe Consulting Group Philippines is recruiting a Pharmacovigilance Specialist on behalf of a reputable multinational pharmaceutical company. The role will report to PV Manager and will be based in BGC, Taguig with hybrid working setup.
Key responsibilities:
- Oversee local Individual Case Safety Reports (ICSR) management, including documentation, forwarding, tracking, and follow-up.
- Manage safety data collection for interventional studies (clinical trials) and organized data collection schemes.
- Monitor the company's sponsored social media and screen local language medical literature for safety information.
- Ensure compliance with patient confidentiality laws and regulations.
- Inform Safety Systems Team (SST) about PSUR requirements and liaise with local regulatory affairs.
- Provide safety information for periodic safety reports upon request.
- Implement and maintain a local tracking system for timely ICSR submissions.
- Monitor Affiliate PV system performance, ensuring compliance and reporting monthly metrics to Global PSRM.
- Stay informed about local and international PV legislations, regulations, and guidelines.
- Communicate changes in local PV regulations to Global PSRM.
- Implement PSRM standards and procedures locally.
- Develop and implement local processes and procedures aligning with PSRM standards, local regulations, and SOPs.
- Act as the key Affiliate contact for internal PV audits and regulatory authority PV inspections.
- Forward regulatory authority communications to required PSRM personnel and ensure timely completion of corrective actions.
- Manage local Safety Data Exchange Agreements (SDEA) and PV agreements in line with global procedures and local requirements.
- Implement and track activities in accordance with Risk Management Plans (RMPs) locally.
- Handle inquiries related to product safety, including regulatory authority inquiries.
- Inform Regional Leads about urgent safety restrictions.
- Handle inquiries related to product safety, including regulatory authority inquiries.
- Inform Regional Leads about urgent safety restrictions.
- Plan PV business continuity and notify of any business interruptions affecting pharmacovigilance processes or regulatory compliance.
- Plan PV business continuity and notify of any business interruptions affecting pharmacovigilance processes or regulatory compliance.
- Other miscellaneous tasks as necessary
Minimum Qualifications:
- Minimum a Medical, Pharmacy or Life-sciences Bachelor's / Master's degree (or equivalent)
- Minimum three years of working experience within the pharmaceutical industry and minimum two years within pharmacovigilance.
- Strong communicator. Excellent project management skills, excellent team working skills, excellent organizational skills and capable of working efficiently in the local team as well as in other cross-functional teams.
- Able to operate internationally with fluent English.
- Proficiency in computer skills, as required
