SME - PCI

Band

Position Overview:

Subject Matter Expert PCI Business

• We are seeking an experienced

  Subject Matter Expert (SME) in Pharmacovigilance Research

  to lead drug safety monitoring, regulatory compliance, and risk assessment initiatives. This role requires deep expertise in pharmacovigilance regulations, adverse event management, and clinical trial safety assessments. The SME will provide strategic guidance, ensure compliance with global regulatory standards, and support process optimization within pharmaceutical and biotech industries.

Key Responsibilities

• Establish and maintain production and quality control protocols for data collection, analysis, and reporting processes
• Develop and implement standard operating procedures (SOPs) for pharmaceutical and patent research workflows
• Monitor data accuracy, completeness, and consistency across all research initiatives
• Conduct regular quality audits and training as needed
• Maintain detailed documentation of quality metrics, process improvements, and validation activities
• Present complex analytical results to stakeholders in clear, actionable formats
• Lead projects while collaborating with different teams and information sources
• Provide pharmacovigilance expertise in clinical trial safety assessments, serious adverse event (SAE) reporting, and regulatory submissions.
• Evaluate and recommend the adoption of advanced technologies (e.g., AI for case processing, automation tools, predictive analytics) to streamline pharmacovigilance operations.
• Business acumen that helps support sales success, ongoing improvements, and relationships with internal and external stakeholders.

Required Skills & Qualifications:

• Education:

  Bachelor's, Masters, or PhD in Pharmacy, Life Sciences, Medicine, or a related field.

• Experience:

  Minimum of

  7+

  years

  in pharmacovigilance, drug safety, regulatory affairs, or clinical research.

• Regulatory Knowledge:

  Deep understanding of pharmacovigilance regulations (FDA, EMA, ICH-GCP, CIOMS, WHO).

• Technical Proficiency:

  Experience with

  pharmacovigilance databases

  (e.g., Argus, ArisG, Veeva Vault), data analytics, and safety signal detection tools.

• Analytical &

  Problem

  -Solving Skills:

  Strong ability to assess risk, interpret complex safety data, and propose strategic solutions.

• Communication &

  Leadership

  :

  Ability to interact effectively with cross-functional teams, regulatory agencies, and external stakeholders.

Skills & Qualifications:

• Education:

  Bachelors or Masters degree in Life Sciences (Pharmacy, Biology, Biochemistry, or related field). Advanced degrees (PharmD, PhD, MD) preferred.

• Experience:

  Extensive experience (typically 5-10 years) in pharmacovigilance, drug safety, or related roles within the pharmaceutical or biotech industries.

• Technical Proficiency:

  Strong understanding of pharmacovigilance systems and software (e.g., Argus, ARISg, Safety Database Management systems).

• Regulatory Knowledge:

  Deep understanding of global pharmacovigilance regulations, clinical safety practices, and reporting requirements.

• Analytical & Problem-Solving Skills:

  Ability to analyze complex safety data and develop evidence-based recommendations.

• Communication & Interpersonal Skills:

  Excellent verbal and written communication abilities to collaborate effectively with cross-functional teams, regulatory bodies, and external stakeholders.

Why join us?

• Opportunity to contribute to business growth of IDS while working closely with MD
• Being a face of MDO for the external stakeholders
• Competitive compensation package with performance-based incentives and opportunities for career advancement.
• Dynamic and collaborative work culture that values innovation, integrity, and excellence.
• Chance to make a meaningful impact by building a business for IDS, client delight, and business growth.