Job Descriptions

Pharmacovigilance Duties (75%)

• Manage local safety activities by the collection, assessment, and reporting of adverse drug reactions and safety data to local regulatory and regional PV function.
• Ensure and maintain all local tracking systems for PV related activities are in place, maintained and up to date.
• Collaborate with healthcare professionals and regulatory authorities to ensure compliance with pharmacovigilance requirements.
• Responsible for the monthly maintenance activities including AE/ADR monthly reconciliation, literature search, regulations, guideline, and directives.
• Follow-up data collection of AE/ADR/specified questionnaires/special situations with business teams and partners.
• Report any potential signal or safety concern to line manager / regional PV.
• Ensure functionality check of PV mailbox, phone numbers, fax number used for medical information or safety reports.
• Provide PV training for new hires and conduct annual refresher trainings to colleagues and business partners.
• Prepare and review RMP for product registration.
• Provide RMP and safety related communication / training to business teams and partners in a timely manner.
• Ensure the latest approved RMP materials are properly reached to HCP.
• Update PV/RMP training materials based on licensing conditions, internal policy, local regulations, and product-related updates.
• Contribute to the preparation of periodic safety reports and regulatory submissions.
• Handle the assigned PV activities and assist ad-hoc/other tasks assigned by line manager.

Regulatory Affairs Duties (25%)

• Manage the pre- and post-registration activities including NCE applications, variations, and renewals.
• Collaborate with cross-functional teams to develop registration strategy and ensure all regulatory requirements are met throughout the product lifecycle.
• Communicate with The Department of Health to respond to their inquiries.
• Provide regulatory document to support tender.
• Communicate with business team or partners, supplies chain, to ensure the approved changes are implemented in a timely manner.
• Support Macau registration and tender activities.

Requirements

• University degree or above in science or Pharmacy.
• Strong skills and knowledge on pharmaceutical-related science areas.
• At least 1-2 years’ experience in western pharmaceutical product familiar with regulatory requirements and pharmacovigilance in Hong Kong.
• Strong analytical, multi-tasking skills and willing to work under pressure.
• Work independently and proactively
• Strong communication skills and a committed, effective team player.
• Proficiency in spoken and written Chinese and English.
• Candidates with more experience may be considered as senior associate.

Work Location: Hong Kong

Hong Kong Work Permit Support: No

We offer attractive remuneration packages and fringe benefit to the right candidates. Interested candidates please email your full resume with current and expected salary, availability to [via CTgoodjobs Apply Now]. 

Please visit our website at https://daiichisankyo.com.hk/index.html to find out more about us. 

We are an equal opportunity employer and welcome applications from all qualified candidates. Information provided will be treated in strictly confidential and only be used for recruitment purpose. Applicants who do not receive response within four weeks may consider their application unsuccessful and submitted information will be destroyed within 4 months.

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