Pharmacovigilance Specialist

About this role

Responsibilities

• Responsibilities include, however not limited to:
• Execute local pharmacovigilance processes and collaborate with internal teams and external partners as assigned
• Manage AE case lifecycle: intake, acknowledgement, tracking, translation to English where applicable, follow-up and reporting of PQCs in line with PV procedures, local regulations and Corporate Policy 01: Patient Safety
• Perform literature screening and Health Authority monitoring and coordinate related submissions (PSURs, RMPs, aggregate reports) as assigned
• Support PV audits, inspections and vendor audits, assist with readiness activities and help develop CAPAs in response to findings
• Review and support negotiation of local PV agreements, conduct local qualification/due diligence and maintain business partner compliance records
• Maintain and update PV controlled documents and training materials, support onboarding and deliver local training as instructed
• Support PV self-inspections, compliance corrective actions for late reports and implementation/oversight of Risk Minimisation Measures as required
• Complete required trainings by due dates prior to performing associated activities
• File, store and archive safety and regulatory documentation per departmental, company and local requirements
• Perform independent QC of selected PV activities and undertake other tasks as requested by the Manager
• What You Must have
• Health, life science, or medical science degree, or equivalent by education/experience
• Work experience and skills
• Pharmaceutical industry experience preferred
• General knowledge of AE reporting and PV regulations preferred, not essential
• Fluency in English (written and spoken) and proficiency in the local language
• Strong communication, organisational and time-management skills
• Ability to work collaboratively across functions and independently with minimal supervision
• Demonstrated ability to drive process improvements that enhance quality or add business value
• What You Can Expect
• Work
• autonomously
• with strong
• support and mentorship
• within a trusted
• global pharmaceutical
• organisation
• Opportunity to
• upskill
• and
• develop your expertise
• through targeted training
• during the contract
• Flexible working
• arrangements and exposure to
• new skills and responsibilities
• A
• collaborative team culture
• with like‑minded colleagues and meaningful
• cross‑functional exposure
• We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when 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 workplace.
• Required Skills:
• Adverse Event Report, Adverse Events, Aggregate Reports, Audit Readiness, Clinical Trial Management, Compliance Awareness, Compliance Investigations, Data Analysis, Data Management, Detail-Oriented, Documentation Controls, Drug Safety Surveillance, ICSR, Literature Evaluation, Periodic Safety Update Reports, Pharmacovigilance, Regulatory Compliance, Regulatory Submissions, Risk Management Strategies, SOP Documentation, Stakeholder Management
• Preferred Skills:
• 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:
• Temporary (Fixed Term)