Senior Manager/ AD, Pharmacovigilance

Location: Remote

Company

Gan & Lee Pharmaceuticals is a pharmaceutical company developing and supporting clinical-stage assets.

What you will do

• Oversee the collection, evaluation, analysis, and reporting of adverse drug reactions across domestic and international markets.
• Formulate and optimize pharmacovigilance processes and strategy to improve the quality and efficiency of safety assessments.
• Lead safety risk assessments, signal detection, and the development and implementation of Risk Management Plans.
• Manage drug safety data, documentation, records, databases, and archiving with a focus on accuracy, completeness, and confidentiality.
• Prepare and review PSUR, PBRER, and DSUR reports, safety narratives, and regulatory submissions.
• Collaborate with Clinical, Regulatory Affairs, regulatory authorities, and external partners; provide training on pharmacovigilance requirements.

Requirements

• Medical degree.
• 5–10 years of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry.
• In-depth knowledge of global pharmacovigilance regulations and drug safety practices, including FDA, EMA, and ICH guidelines.
• Experience with pharmacovigilance systems and databases such as Argus and ArisGlobal, regulatory submission systems, data processing software, and MedDRA coding.
• Experience providing safety input for multiple global clinical trials and presenting safety data to internal and external stakeholders.
• Strong analytical, prioritization, communication, relationship-building, and problem-solving skills.

Culture & Benefits

• Fully remote work arrangement.
• Collaboration with Clinical Operations, Regulatory Affairs, regulatory authorities, and external partners.
• Work supporting safety and continued benefit-risk evaluation across international markets.