Medical Affairs Executive (1-year renewable contract)

Menarini; Selangor; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading healthcare company in Malaysia is seeking a Medical Affairs Executive on a 1-year renewable contract. The role involves managing pharmacovigilance processes, ensuring compliance with local regulations, and supporting the medical affairs department with various tasks. Candidates should possess a Bachelor's degree in Pharmacy or a related field and demonstrate proficiency in English along with strong communication and organizational skills. Competitive compensation and professional development opportunities await the right candidate.

Qualifications

• Bachelor degree in Pharmacy / Medical or related discipline.
• Knowledge of pharmacovigilance and medical affairs.
• Experience in managing adverse event reporting and safety data.

Responsibilities

• Manage pharmacovigilance (PV) for Menarini.
• Act as the Local Drug Safety Unit Manager Deputy.
• Ensure compliance with legal PV requirements.
• Train and audit compliance with PV quality systems.
• Manage adverse event reporting and local guidelines.

Skills

Proficient in oral & written English

Computer literate (Word, Excel, PowerPoint)

Communication skills

Organizational skills

Inter-personal skills

Education

Bachelor degree in Pharmacy / Medical or related discipline

Job description

Medical Affairs Executive (1-year renewable contract)

Responsible for management of pharmacovigilance (PV) for A. Menarini.

Support the medical affairs department on assigned responsibilities.

Updating manager on PV / MA risks identified, and propose solutions in a timely manner.

Keeping abreast and updating Management PV changes/updates in the local laws, requirements and guidelines.

Duties and Responsibilities:

• Act as the Local Drug Safety Unit Manager Deputy & RPPV Deputy
• Ensure the PV system complies with legal PV requirement in place
• Responsible for the management of PV quality system activities at local level according to Global PhV procedures, IDSCU and applicable requirements (local ones and guidelines), including but not limited to:

• Training
• Audit planning, execution, report and relevant follow up
• Coordination of activities during Authorities and Partners inspections
• Deviation and corrective and preventive actions (CAPAs) management
• Management of local SOPs and WIs as applicable, in compliance with Global SOPs
• Implementation and management of PV KPI

Responsible for regulating information and activities flow in place between LDSU and IDSCU which includes but not limited to:

• Update of local guidelines / regulation
• Timely preparation and submission of routine reports
• Management of Safety Data Exchange Agreement (SDEA) & ensure PV activities are performed in compliance with SDEA /Pharmacovigilance Agreement (PVA) with Partners

Management of adverse event/incident/vigilance reporting at local level according to local regulations, Global and Regional PhV procedures including but not limited to:

• Ensure that all adverse events and follow up reports are reported to relevant competent authorities (including Mandatory Problem Reporting to MDA), business partner, Global and Regional PV in accordance to reporting timelines
• Maintenance of local AE tracking log
• Maintaining copies of all documentation for each adverse event report
• Providing IDSCU with the submission date and acknowledgement receipt from the local competent authority
• Management of local literature screening subsequent management of AE / SAE detected.
• Management of Clinical trials/post marketing studies safety reporting
• Perform timely reconciliation of adverse event reports

Management of safety update reports (PSUR / RMP) at local level according to local regulatory requirements, Global and Regional PhV procedures, including but not limited to:

• Updating IDSCU with the updated aggregate report planning in a timely manner
• Ensures the submission of expedited report and PSURs to local competent authority within stipulated timelines and providing IDSCU with the submission date and acknowledgement receipt from the local competent authority
• Perform other PV related activities as necessary

Medical Affairs

Ensure timely documentation, tracking and response of all MIE enquiries including responding to unsolicited medical enquiries with scientifically accurate, objective, consistent responses with up-to-date scientific data and local package insert.

Support medical affairs department for training, promotional material review, artwork review and other assigned responsibilities.

Support for SOP updates.

Others

• Coordinating with other departments on matters related to MA and PV when required.
• Performs other tasks that may be assigned from time to time.

Position Requirements/Qualifications

Bachelor degree in Pharmacy / Medical or related discipline.

Knowledge & Skills: Proficient in oral & written English, computer literate (Word, Excel, PowerPoint), communication skills, organizational skills and inter-personal skills.