A. Menarini Asia Pacific – Pharmacovigilance Executive

POSITION SUMMARY:

You will report to the Associate Regional Pharmacovigilance Manager and will assume primary responsibility in management of pharmacovigilance quality system, adverse event processing, and safety information communication for all spontaneous and solicited adverse events with Corporate Pharmacovigilance Department.

KEY RESPONSIBILITIES:

You will:

• Act as the International Drug Safety Coordinating Unit Deputy and deputizes as International Drug Safety Coordinating Unit Manager (IDSCUM) in the absence of the IDSCUM.
• Assist in oversight, monitoring and ensuring compliance of all regional and local product vigilance processes in Asia Pacific.
• Support IDSCUM for the management of Pharmacovigilance activities at Regional Level.
• Responsible for all adverse events and safety information reporting to Corporate Pharmacovigilance and Regional in-licensed partners.
• Responsible for the coordination of worldwide safety reporting with local affiliates, corporate or licensed partners based on the country regulations.
• Support the management of PV quality management system activities accordingly, including but not limited to the following activities:
• Deviation, corrective action and preventive actions (CAPAs) management;
• Management and issuance of Regional SOPs and WIs as applicable, in compliance with Corporate SOPs; 
• Reconciliation with Corporate and partners.
• Support in the management of Safety Data Exchange Agreements (SDEAs) with Partners/Distributors and the activities are performed in compliance with the respective SDEAs.
• Support in coordinating and monitoring compliance of Aggregate Safety Reports and Safety Profile monitoring processes in the Local Drug Safety Units (LDSUs) in Asia Pacific (PBRERs, LLs, RMPs, etc.)
• Responsible for the coordination of cross function training in collaboration with other GxP impacted functions within Regional Office and act as the training coordinator:

KNOWLEDGE/ QUALIFICATIONS / SKILLS / EXPERIENCE:

You should

• Possess a Diploma/Degree in Health Sciences or related discipline
• Come with 1 to 2 years of experience in Pharmaceutical Industry, preferably in Pharmacovigilance. However candidates with no experience are also welcome
• have experience with management of safety information for clinical trials would be an advantage
• have basic knowledge of medical terminologies
• have basic MS office and administrative skills
• have strong verbal and written communication skills
• be able to work under tight timelines
• possess excellent organizational skills with the ability to find solutions (technical and non-technical) in a complex environment
• have experience in safety database base (ARISg or Argus), will be an advantage