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- Tasks: Manage local pharmacovigilance activities and ensure compliance with regulations.
- Company: Join a leading pharmaceutical company dedicated to patient safety.
- Benefits: Professional development, hybrid work options, and a collaborative team environment.
- Other info: Dynamic role with opportunities to lead projects and collaborate across functions.
- Why this job: Make a real impact on patient safety while growing your expertise in pharmacovigilance.
- Qualifications: Degree in health or life sciences and extensive pharmacovigilance experience preferred.
The predicted salary is between 50000 - 65000 ÂŁ per year.
Weâre seeking a hands-on Senior PV Specialist to join our UK & Ireland country operations team. Youâll take ownership of local PV activities, keep us compliant, and be a trusted partner to local business teams. On a day-to-day basis youâll support the management of local initiatives and data sources, assist with audits and inspections, maintain PV systems and documentation, and oversee ARMM and RMP activities.
This role suits someone who is organised, proactive and enjoys working across functions and with global PV stakeholders. In a challenging, fastâmoving environment youâll make a direct impact, solve complex problems and grow your PV expertise.
What youâll do:
- Execute local PV processes and ensure compliance with local legislation and global procedures (AE case handling, aggregate reports, patient programmes, local PV agreements).
- Support the management of adverse event intake, triage, follow-up and submissions.
- Support PV audits, inspections and self-inspections; contribute to development and closure of CAPAs.
- Maintain local PV documents, training materials and local training resources; support onboarding of new colleagues.
- Support aggregate report operations; scheduling, coordinating and maintaining timely submission of aggregate safety reports.
- Implement local Risk Management Plans (RMPs) and associated risk-minimisation activities.
- Implement and oversee Risk Minimisation Measures and Additional Risk Minimisation Measures.
- Monitor Health Authority communications and advise stakeholders; represent PV in cross-functional meetings.
- Review local initiatives (marketing, patient programmes, digital tools) for PV compliance.
- Support business continuity plans and participate in projects that improve PV processes.
What we need from you:
Education: Degree in health, life sciences or medical sciences, or equivalent experience.
Experience: Extensive PV experience in the pharmaceutical industry preferred (or equivalent experience). Strong knowledge of AE reporting, UK and EU PV regulations and PV quality systems. Experience with PV audits or Health Authority inspections preferred.
Key skills: Fluent in English (written and spoken). Excellent communication and stakeholder-management skills. Strong organisation, prioritisation and project-management abilities. Comfortable working independently and collaborating across functions. Effective negotiation and influencing skills; able to drive improvements. Strategic mindset with a strong attention to quality and regulatory compliance.
Desirable: Previous experience in the UK Pharmacovigilance environment. Experience with ARMM and RMP activities.
Why join us: You will play a visible role in keeping patients safe and enabling our business teams to operate with confidence. We offer opportunities to lead projects, develop professionally and work with a collaborative, cross functional team.
Senior Pharmacovigilance Specialist employer: MSD Malaysia
Contact Detail:
MSD Malaysia Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Senior Pharmacovigilance Specialist
â¨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in pharmacovigilance. A friendly chat can lead to insider info about job openings or even referrals.
â¨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU PV regulations. We want you to showcase your expertise and confidence when discussing compliance and risk management during those crucial conversations.
â¨Tip Number 3
Donât underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
â¨Tip Number 4
Apply through our website! Itâs the best way to ensure your application gets noticed. Plus, it shows youâre genuinely interested in joining our team and making a difference in patient safety.
We think you need these skills to ace Senior Pharmacovigilance Specialist
Some tips for your application đŤĄ
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your PV experience and any relevant projects you've worked on, so we can see how you fit into our team.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about pharmacovigilance and how your background aligns with our needs. Be sure to mention any specific achievements that demonstrate your expertise in compliance and stakeholder management.
Showcase Your Communication Skills: Since this role involves a lot of cross-functional collaboration, make sure to highlight your communication skills in both your CV and cover letter. We want to know how youâve effectively communicated with stakeholders in the past.
Apply Through Our Website: Donât forget to submit your application through our website! Itâs the best way for us to receive your details and ensures youâre considered for the role. Plus, itâs super easy to do!
How to prepare for a job interview at MSD Malaysia
â¨Know Your PV Regulations
Make sure you brush up on your knowledge of UK and EU pharmacovigilance regulations. Being able to discuss these confidently will show that you're not just familiar with the basics, but that you understand the complexities involved in compliance.
â¨Showcase Your Organisational Skills
Prepare examples that highlight your organisational and project management abilities. Think about times when you've successfully managed multiple tasks or projects, especially in a fast-paced environment, and be ready to share those stories.
â¨Engage with Stakeholders
Since this role involves cross-functional collaboration, think about how you've effectively communicated and negotiated with different stakeholders in the past. Be prepared to discuss specific instances where your communication skills made a difference.
â¨Prepare for Compliance Questions
Expect questions around compliance monitoring and risk management plans. Familiarise yourself with common challenges in these areas and be ready to discuss how you've tackled similar issues in your previous roles.