Pharmacovigilance (PV) Manager (Regional)

2 weeks ago

Singapore DAIICHI SANKYO SINGAPORE PTE. LTD. Full time $120,000 - $240,000 per year

The Pharmacovigilance (PV) Affiliate Manager and Cluster Lead (Singapore/Australia) is a PV cluster lead position overseeing local PV system in the assigned countries (i.e. Singapore, Australia) as a local PV responsible person, and is responsible for ensuring compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally.

Job Description

  • Overall responsibility for the implementation and maintenance of PV processes/procedures in the cluster countries in line with regulatory requirements and company procedures.

  • Act as the National Contact Person for Pharmacovigilance (NCCPV) if required by local legislation, and/or LSO on the relevant Cluster Countries

  • Implement and maintain PV processes and procedures in alignment with regulatory and internal standards.

  • Ensure timely and complete responses to Health Authority (HA) safety requirements.

  • Monitor regulatory changes and assess impact on PV systems.

  • Lead inspection readiness locally in close cooperation with global/regional teams and act as SME during audits and inspections in the designated countries.

  • Oversee the performance of PV activities in line with the defined KPIs, implementation of all necessary CAPAs and process improvements

  • Report performance metrics and deviations to DS Global.

  • Oversight of PV vendors, their qualification and training (as applicable).

  • Coordinate and maintain backup arrangements to ensure PV operational continuity.

  • Create and update local procedures based on regulatory requirements and global processes.

  • Maintain and regularly update local Standard Operating Procedures (SOPs) to ensure alignment with current regulatory requirements and global PV processes.

  • Prepare and implement PV agreements with license partners and PV service providers.

  • Ensure PV clauses in locally organized data collection project (ODCP) contracts clearly define adverse event collection and that the process is effectively executed.

  • Oversee collection, reconciliation, and submission of safety reports for both of ICSR and Aggregate report.

  • Review local scientific literature for adverse drug reactions (ADRs) and potential safety signals.

  • Develop and deliver PV training to affiliate staff and vendors.

  • Locally implement Risk Management Plans (RMPs). additional risk minimization measures and safety communications, ensuring translation, regulatory negotiation, and effective execution.

  • Collaborate with local cross-functional teams to ensure PV compliance in affiliate activities. (e.g. Support local non-interventional studies and ODCP (Organized Data Collection Program), local affiliates sponsored digital initiatives including company websites).

  • Ensure business continuity and crisis response systems are in place.

Job Requirement

  • Bachelor's degree in life science, pharmacy, or medical sciences at minimum; 6-9 years of PV experience with an advanced degree; 8-11 years of PV experience with a bachelor's degree.

  • Proficient in English; fluent in at least one of the local languages is preferred.

  • Proficiency in multiple local languages is a plus.

  • Extensive knowledge of local, and international PV regulations.

  • Demonstrated leadership and operational experience in matrix organizations, including people management and cross-functional collaboration.

  • Experience in regulatory authority engagement.

  • High reliability and accuracy in operations.

  • Analytical and systematic problem-solving approach.

  • Strong communication skills and cultural adaptability.

  • Proactive, autonomous, and dependable work style.

  • Pharmacovigilance (PV) Manager / Medical MNC

    2 weeks ago

    Singapore River Integrity Partners Pte. Ltd. Full time $90,000 - $120,000 per year

    We are looking for a seasoned PV (pharmacovigilance) professional to lead pharmacovigilance activities.You will ensure compliance with both local and global regulatory requirements while driving operational excellence and strategic alignment with global PV teams.KEY REPOSNSIBILITIES:Oversee and implement local PV systems and act as primary contact with...

  • Pharmacovigilance Cluster Lead and Affiliate Manager

    2 weeks ago

    Singapore Ethos BeathChapman Full time

    Pharmacovigilance Cluster Lead and Affiliate Manager Join to apply for the Pharmacovigilance Cluster Lead and Affiliate Manager role at Ethos BeathChapman Location: Singapore (Hybrid)An international biopharmaceutical organisation is seeking a Pharmacovigilance Cluster Lead and Affiliate Manager to oversee PV systems across Singapore and Australia . This...

  • Pharmacovigilance Senior Specialist

    2 days ago

    Singapore MSD Full time

    Overview Pharmacovigilance Senior Specialist role at MSD . Based in Singapore, the regional hub for Asia Pacific (AP). Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to...

  • Pharmacovigilance Area Head, Apac

    3 days ago

    Singapore Takeda Pharmaceutical Full time

    **OBJECTIVE**: - Responsible for overseeing the quality management and compliance activities as they relate to Post-Market Safety of the applicable affiliate office(s) in the APAC Area. - Supports and provides audit/inspection readiness and pharmacovigilance oversight, functional expertise and leadership to the Cluster and/or Country Leads within the...

  • Pharmacovigilance Senior Specialist

    1 week ago

    Singapore MSD Full time

    **Job Requirements **THE OPPORTUNITY** - Based in Singapore, the regional hub for Asia Pacific (AP) and named one of the Best Companies to Work for in 2019 by HR Asia - Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our Clinical Research and Pharmacovigilance team push the boundaries...

  • Pharmacovigilance Cluster Lead and Affiliate Manager

    1 week ago

    Singapore BEATHCHAPMAN (PTE. LTD.) Full time

    Roles & Responsibilities Location: Singapore (Hybrid)An international biopharmaceutical organisation is seeking a Pharmacovigilance Cluster Lead and Affiliate Manager to oversee PV systems across Singapore and Australia . This pivotal role ensures patient safety, regulatory compliance, and operational excellence within a dynamic regional environment.You’ll...

  • Regulatory Affairs and Pharmacovigilance Specialist

    3 days ago

    Singapore Novo Nordisk Full time

    Regulatory Affairs and Pharmacovigilance Specialist **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Singapore, Singapore, SG **About the department** Novo Nordisk Singapore supports both Singapore and Brunei. Our team is dedicated to ensuring regulatory compliance for new products and product amendments, thereby maintaining our license to...

  • Director Pvqa, Apac

    1 week ago

    Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    **Director PharmacoVigilance Quality Assurance (PVQA) - APAC** Location : Singapore Department : R&D PV QA Reporting to : Head of Global PVQA Territory : Asia Pacific Travel % : up to 30% **ABOUT THE BUSINESS** Our client is a global pharmaceu8cal company with more than 100 years of scientific expertise and specializes in developing oncology and...

  • Senior Specialist, Drug Safety

    1 week ago

    Singapore Organon Full time

    **The Position** The Senior Drug Safety Specialist is responsible for all assigned pharmacovigilance activities and may serve as the point of contact with local stakeholders, headquarters and the local health authority. Reporting to the Associate Director Drug Safety based in Melbourne, Australia, the Senior Drug Safety Specialist collaborates with...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Singapore Pharmaforte Singapore Pte Ltd Full time

    Job Description: Ensuring timely regulatory submissions for new products, indications, renewals and variations to maintain current registration of all products. Liaising with and ensuring compliance with HSA as well as Principal's requirements pertaining to post-market activities. Review and approval of advertising and promotional materials. Ensuring...