• Degree in life, health, or pharmaceutical sciences is preferred
• Experience in 1-3 years in PV or similar
• Immediate availability is highly preferred

Responsibilities:

1. Aggregate Reporting & Compliance
• Review, translate, prepare, submit, and track local aggregate reports in accordance with regulatory requirements.
• Coordinate submission timelines with Global Medical Safety (GMS) and local Regulatory Affairs to maintain alignment with the Global Aggregate reporting schedule.

2. Local Regulatory Intelligence
• Monitor and evaluate changes in local PV regulations, performing impact assessments on global and local procedural documents.
• Implement new or updated PV regulations and provide input to enhance LMS-wide processes, systems, and policies.
• Engage in local industry associations to drive policy-shaping initiatives.

3. Pharmacovigilance Service Provision
• Oversee day-to-day safety activities for both medicinal products and medical devices.
• Collaborate with the local Marketing Authorization Holder (MAH) to fulfill regulatory obligations and business objectives.
• Manage local Pharmacovigilance Agreements (PVAs) and ensure appropriate PV language is integrated into vendor contracts.
• Establish processes for the implementation and maintenance of the local Pharmacovigilance System Master File (PSMF) and handle Health Authority (HA) safety queries.
• Support Data Generating Activities/Related Research Activities to ensure proper safety monitoring and potential AE reporting.

4. Local Benefit-Risk & Product Compliance
• Act as the Therapeutic Area (TA) and product safety expert in cross-functional teams to contribute safety insights for strategy development.
• Review and localize Risk Management Plans (RMPs)/Addendums, participate in additional risk minimization activities, and negotiate agreements with the local HA.
• Support the implementation of the Company Core Data Sheet (CCDS) into local labeling (e.g., SmPC, Patient Leaflet).
• Communicate new relevant safety information to GMS and local stakeholders, and participate in local safety signal detection as required.

5. Safety Training Management
• Support the global rollout of Adverse Event (AE) and Product Quality Complaint (PQC) training within the local operating company.
• Deliver safety training to internal stakeholders, distributors, and vendors, including the translation of training materials where necessary.

Qualifications & Experience:

• Education: Degree in life, health, or pharmaceutical sciences is preferred; strong proficiency in medical terminology.

• Experience: Minimum of 2+ years of pharmaceutical industry experience, with at least 1 year dedicated to a product vigilance/PV responsibility role.

• Languages: Fluency in English and the national/local language(s) is required.

• Key Skills:
o Excellent communication, negotiation, and relationship-building skills with internal teams and external authorities.
o Strong analytical and root-cause analysis skills to resolve process gaps innovatively.
o High computer proficiency (e.g., MS Office) and deep knowledge of global/local PV Standard Operating Procedures (SOPs).
o Ability to work independently with minimal supervision while meeting tight deadlines.

Interested parties please send your full resume with your current and expected salary to charmaine.tang@manpowergrc.hk