Job Description
Summary This position is responsible for overseeing pharmacovigilance activities to ensure the safety and compliance of pharmaceutical products. The role involves monitoring, detecting, assessing, and reporting adverse drug reactions (ADRs), as well as ensuring effective risk management and regulatory compliance across domestic and international markets. This individual will collaborate with clinical operation teams, regulatory authorities, and other stakeholders to support the safety and continued benefit-risk evaluation of products. The position reports to the head of Clinical Science.
Education and Experience - Master's degree in life sciences or a related field with 2+ years of of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry.
Skills and Qualifications - In-depth knowledge of global pharmacovigilance regulations and drug safety practices, including FDA, EMA, and ICH guidelines.
- Strong analytical and problem-solving capabilities, with meticulous attention to detail and the ability to accurately interpret and assess safety data.
- Proficiency with pharmacovigilance systems and databases (e.g., Argus, ArisGlobal). Proficient in data processing software, safety databases, regulatory submission systems, and MedDRA coding.
- Skilled in presenting and critically discussing safety data in both internal and external settings.
- Extensive experience providing safety inputs for multiple global clinical trials.
- Demonstrated ability to manage multiple tasks simultaneously, prioritize effectively, and identify key issues.
- Outstanding communication skills, with a proven ability to build and maintain strong relationships with regulatory authorities, internal teams, and external partners.
Responsibilities - Formulate and optimize pharmacovigilance processes and strategy to improve the efficiency and quality of safety assessments and monitoring.
- Oversee the collection, evaluation, analysis, and reporting of ADRs, ensuring compliance with global drug safety monitoring standards.
- Lead drug safety risk assessments, signal detection activities and the development and implementation of Risk Management Plans (RMPs), promptly identifying and evaluating potential drug safety risks.
- Lead and oversee the management of drug safety data, pharmacovigilance documentation and record, ensuring the accuracy and completeness and confidentiality.
- Participate in pharmacovigilance external audits and regulatory inspections, ensuring compliance with all applicable regulations.
- Lead the preparation and review of drug safety reports (e.g., PSUR, PBRER, DSUR) to ensure compliance with global regulatory standards. Assist in the preparation of safety narratives and regulatory submissions
- Ensure accurate documentation and archiving of pharmacovigilance data in safety databases. Provide regular drug safety updates to management, regulatory agencies, and partners, ensuring transparency and compliance in pharmacovigilance activities.
- Collaborate closely with Clinical, Regulatory Affairs, and other departments to ensure timely and effective communication and sharing of drug safety information.
- Provide training to internal teams and external partners on pharmacovigilance processes and requirements.
Gan & Lee Pharmaceuticals
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