Pharmacovigilance Country Lead
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD is home to a diverse team of scientists and researchers who are working to push the boundaries of global healthcare through research and innovation. Relentlessly curious and driven, the Pharmacovigilance team produces effective, reliable medicine through clinical trials and surveillance that uncovers new knowledge, product discovery, and leading-edge medical breakthroughs.
The Pharmacovigilance (PV) Country Lead is responsible for the day-to-day PV activities within his/her country(ies) including compliance with PV processes and regulations, MSD policies and procedures, representing MSD for safety issues at the country level and interfacing with the country heads of Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to ensure alignment on issues impacting PV.
- Manage adverse experience cases including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per MSD’s procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements
- Handle aggregate safety report submission, including report scheduling, submissions and submission compliance entries in accordance with Global Safety procedures and health authority requirements.
- Reconcile adverse events reports received from other MSD operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
- Create pharmacovigilance reports based on country agreements, working with the Regional Support Officer (RSO) and liaising, as necessary, with the business partner
- Update and maintain the master contract list with respect to local contracts, develop and maintain the necessary PV process(es) to ensure early awareness by PV and review of business agreements for PV language requirements with Global Safety procedures
- Audit and inspect activities in Malaysia, including internal audits, verification audits, local BP audits
and health authority inspections. Dependent on the audit/inspection type, responsibilities include work on readiness activities
- Review local initiatives (e.g., websites, registries, marketing initiatives), local clinical evaluations, market research, post-marketing active surveillance (PMAS), patient support programs (PSPs) and post authorization safety studies (PASS) protocols for compliance with PV requirements, as applicable
- Accountable for the delivery, documentation and tracking to completion of training for PV staff, customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope
- Bachelor's Degree, Post Graduate Diploma, Professional Degree, Master's Degree, Doctorate (PhD), Medical Science, Pharmacy/Pharmacology or equivalent
- Extensive knowledge of Pharmacovigilance regulations within Malaysia
- Minimum 8 year(s) of working experience in the related field is required for this position
- At least 3 years of pharmacovigilance experience
- Experience working in a registered pharmaceutical/ multinational pharmaceutical company
- Strong management and leadership skills
- Excellent English communication skills
- Willing to travel domestically or internationally
For those who are interested, send your CV’s to firstname.lastname@example.org, or click on the link to apply: https://jobs.msd.com/MSD/job/Petaling-Jaya-PV-Lead%2C-Malaysia-Job-B/457394600/.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.