Full-Time Sr. PV Officer

Job Responsibilities:

• Supporting project team activities for the client.
• Handling ICSR management within agreed timelines and scope, including:
• Processing ICSR reports from all sources, adhering to regulations, PrimeVigilance procedures, and client requirements.
• Following up on ICSR reports.
• Managing SAE/SUSAR, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review.
• Performing reconciliations (clinical, partners).
• Protecting personal data.
• Handling product quality complaints and interacting with Quality Assurance.
• Interacting with Medical Information.
• Coding using MedDRA and WHO standards.
• Generating database outputs and reports, including monthly client reporting.
• Managing workflow and resources.
• Mentoring and training junior employees.
• Supporting PV processes related to ICSR management within PrimeVigilance and clients.
• Supporting ICSR SMEs and contributing as an ICSR SME.
• Supporting ICSR Operational Leads and Director of ICSR as needed.
• Qualifications and Experience:
• Life science, pharmacy, nursing, or other healthcare-related degree/experience in pharmacovigilance.
• 6-7 years of experience in pharmacovigilance, with SAE processing and SUSAR submission experience in clinical safety.
• Skills and Abilities:
• Excellent written and verbal communication skills.
• Strong organizational skills, attention to detail, and multitasking abilities.
• Planning and time management skills.

Company Information:

We prioritize diversity, equity, and inclusion; provide training and career development opportunities; emphasize personal and professional growth; have a friendly, supportive environment; have colleagues globally, primarily speaking English; and uphold core values.

Our Values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships.

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