Job Description

Senior Drug Safety Specialist

THE OPPORTUNITY

• Opportunity to be a part of the Strategic Partnerships team in Singapore!

• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for four consecutive years (2020, 2021, 2022, 2023) as well as Great Place to Work-Certified™ company.

• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

The Specialist, PV is responsible for PV activities which may include but is not limited to PV Intake activities (including reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due diligence activities, supporting audits and inspections and related readiness activities, authoring local SOPs, conducting local training, and archiving and is able to perform these tasks with minimal supervision.

The Specialist, PV may serve as the Back-up (BU) local Qualified Person for PV (QPPV) / BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation. In the absence of the PV Lead, they may manage day-to-day PV activities and serve as their back-up.

What you will do:

• Serves as the point of contact for the local Health Authority for PV related questions when assigned by the PV Lead and in their absence. If serving as the local QPPV / Local PV Contact / Local Responsible PV Person or Backup, complies with all requirements mentioned in the local laws and regulations.

• Responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.

• Responsible for day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.

• Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety.

• May coordinate translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable).

• Supports local PV audits and inspections including readiness activities and supports audits of business partners/vendors including the development of CAPAs in response to findings/observations as assigned.

• Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports.

• Assists in developing and maintaining local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.

• May support PV Lead in maintaining the local PV Training matrix and onboarding plans. May support development and maintenance of local PV controlled documents (i.e., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.

• Supports PV self-inspections as required by PV Legislations (where applicable).

• Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.

• Supports training of local company staff, distributors, vendors, and business partners as instructed by their manager.

• Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).

• May be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).

• May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews, and ensuring maintenance of the business partner data tracking system.

• As delegated by PV Lead, collaborates with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (as applicable).

• May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.

• As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation (as applicable).

• May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations. As assigned by PV Lead, prepare/maintain/submit local RMPs to the local HA (as applicable).

• Support local implementation of applicable business continuity plans (as applicable) Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.

• Serves as local Subject Matter Expert on relevant PV regulations, processes, and procedures. Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions.

• Represents PV in cross-functional organizational and alliance partner forums as needed.

• Participates on local company committees and councils for matters impacting PV as assigned.

• May participate on special projects or rotational assignments within or outside of IPV as part of their professional development.

Additional Local Specific Activities:

• Senior Specialist, PV located in Singapore is the contact person for the Health Sciences Authority in Singapore for pharmacovigilance and is the contact person for Singapore and Brunei pharmacovigilance activities. The position reports to the PV Lead in Malaysia (PV Lead for Singapore/Malaysia)

What you should have:

• Health, life science, or medical science degree or equivalent

• At least 2 years of experience in the pharmaceutical industry is preferred

• Supervisory experience managing people/teams/contractors is preferred if the position will be managing staff

• In-depth knowledge of AE reporting requirements and relevant PV regulations, PV quality management systems and be an expert in PV processes and activities.

• Experience with PV audits and/or PV Health Authority Inspections

Other Personal Attributes:

• Must be fluent in English (written and spoken) while proficient in local language

• Ability to travel within the region and globally

• Advanced interpersonal communications, organizational, and presentation skills

• Ability to work in partnership with others (internally and externally)

• Advanced negotiation and influencing skills

• Ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.

• Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.

• Demonstrates advanced strategic thinking and project management skills including prioritization of tasks.

WHAT YOU CAN EXPECT

• Limitless opportunities for career growth

• A state-of-the-art facility that delivers solution to its customers world-wide

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adverse Drug Reaction (ADR) Monitoring, Applied Engineering, Audit Process Evaluations, Business Continuity, Business Decisions, Business Relationship Management (BRM), Clinical Trial Oversight, Communication, Compliance Investigations, Compliance Program Development, Detail-Oriented, Diplomacy, Drug Safety Surveillance, Management Process, Medical Knowledge, Partner Relationship Management (PRM), Patient Safety, Pharmacovigilance, Post Marketing Surveillance, Regulatory Communications, Regulatory Compliance, Regulatory Reporting, Stakeholder Management, Stakeholder Relationship Management, Translations

Preferred Skills:

Job Posting End Date:

10/9/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.