Senior Manager - Pharmacovigilance/ Medical Affairs

View: 108

Update day: 07-05-2024

Location: Southampton South East

Category: Legal / Contracts

Industry: Pharmaceuticals Mental Health Care Medical Devices

Position: Associate

Job type: Full-time

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Job content

Senior Manager - Pharmacovigilance/ Medical Affairs

Leading Biotech Company

Career Progression

About Our Client

Our client is a leading biotechnology company with global presence and the role is based in Hong Kong.

Job Description

Provide medical and safety expertise as the Medical Safety and prepresentative in the medical affairs team.
Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents.
Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents including Investigators Brochures, clinical trial protocols, safety management plans, study reports, integrated safety summary and summary of clinical safety.
Manages and conducts ongoing safety surveillance on assigned products. Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary.
Organize and conduct safety management meetings for assigned products and responsible for safety surveillance, signal detection and risk management.

The Successful Applicant

Bachelor Degree in Science (Pharmacy degree preferred)
Master Degree or above in medical science in or related discipline
Experience in the oncology therapeutic area is preferred
At least 5-6 years of experience in pharmaceutical/biotech industry
A self-starter who can thrive in a multi-disciplinary, collaborative, fast-paced, and team-oriented environment with an entrepreneurial spirit
Good communication skills

What’s On Offer

Competitive salary package will be offered to the right candidate.

Contact: Janice Chan
Quote job ref: 4209099

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