Area Safety Officer

Job Description

Pharmacovigilance Specialist (12 Month Fixed Term Contract Maternity Cover)

Location: Manila, Philippines (Hybrid, 3 days in office Monday to Wednesday)

Start Date: As soon as possible

Contract Type: Full Time, 12 Month FTC (Not expected to extend)

Interview Process: Two stages

Timeline: Targeting completion before end of year

About the Role

We are seeking a Pharmacovigilance Specialist to support local vigilance activities across consumer health, cosmetic and device product portfolios. This position operates within a structured regional and global safety framework and provides essential day to day support to ensure compliance with all local pharmacovigilance requirements.

This is a 12 month maternity cover based in Manila with a hybrid working model requiring office attendance Monday to Wednesday. The ideal candidate will bring solid knowledge of pharmacovigilance processes, strong regulatory understanding, and the ability to operate responsibly in a fast paced, compliance driven environment.

Key Responsibilities:

Local Nominated Person Responsibilities

Act as the nationally nominated person, or back up, for local pharmacovigilance as required by national regulations.

Support local PV responsibilities, ensuring adherence to applicable laws and internal procedures.

Safety Management and Reporting

Monitor regulatory developments impacting vigilance obligations.

Conduct reconciliations with internal teams, external partners, distributors and vendors.

Review local literature for identification of adverse events when required.

Submit safety reports and updates to Health Authorities, including SAE, SUE, SUSARs, PSURs, RMPs and other required documentation.

Assist in responding to Health Authority safety queries.

Support notification of safety issues including signals and emerging safety information.

Maintain awareness of local vigilance requirements across pharmaceuticals, cosmetics and devices.

Document and report non-conformances, collaborate with global teams to investigate issues and support CAPA development.

Manage document control, archiving and translation of PV documents and ICSRs.

Deliver training to local teams on safety reporting and maintain ongoing awareness of reporting obligations.

Procedural Document Management

Develop, maintain and implement local procedures aligned with global PV procedures and national requirements.

Ensure all relevant training and procedural understanding is consistently maintained.

Audit and Inspection Readiness

Support audits and inspections by preparing materials, responding to questions and participating in CAPA planning as needed.

PV Contract Management

Provide and review pharmacovigilance clauses for inclusion in local agreements.

Ensure contractual PV responsibilities are accurately reflected and maintained.

Business Continuity

Support the execution of local business continuity plans, ensuring vigilance functions remain stable and compliant.

Must Have Qualifications and Experience

Life sciences or healthcare professional background such as pharmacy, nursing or equivalent.

One to two years of pharmacovigilance experience.

Pharmaceutical industry experience with an understanding of regulatory environments.

Strong English communication skills.

Proficiency with standard computer applications and PV related systems.

Ability to work effectively with internal and external stakeholders.

Availability for hybrid working with mandatory office attendance Monday to Wednesday.

Ability to start as soon as possible, ideally by the second week of January.

Nice to Have Qualifications and Experience

Three to four years of pharmacovigilance experience.

Mandarin or Chinese language capability.

Experience with ICSR processing or local safety reporting.

Background in consumer health, cosmetics or medical device vigilance.

Experience in a regional or global PV setting.

Working Structure and Contract Details

Full time role on a 12 month fixed term contract providing maternity cover.

Hybrid work model with required onsite presence Monday to Wednesday.

Contract is not expected to extend beyond twelve months due to the nature of the role.

Two stage interview process.

The selection process is planned to be completed before year end.