Hiring company: Merck
Job Description
The Pharmacovigilance (PV) Specialist is responsible for the day-to-day case management activities within the country(ies) covered by the country operation including compliance with PV processes and regulations and our Company policies and procedures. He/she is able to function independently in the processing of adverse events.
This includes the procedural responsibilities in the areas of:
Adverse experience case management including HA submissions; aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and aggregate safety reports. As requested by the PV Country Lead, the PV Specialist may undertake other additional activities including projects.
The position reports to the PV Country Lead.
Major Activities and Responsibilities
Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per our Company’s procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.
Responsible for the reconciliation of adverse events reports received from other our Company operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
Responsible for the filing, storage and archiving of safety-related data in accordance with our Company’s policies and local requirements.
Serve as the local Deputy Qualified Person for PV (QPPV) / deputy local responsible PV person for the country(ies) when delegated by PV Country Lead.
Serve as back-up in the absence of the PV Country Lead to ensure business continuity.
Responsible for being compliant with local PV regulations, our Company policies and procedures and Global Safety procedures at the country level.
Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
Identify and communicate potential safety issues to PV Country Lead.
Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.
Complete and document required PV training within the required timelines.
Perform other activities as requested by the PV Country Lead.
Other Activities
Liaise with Data Management Centers and Global Safety Global Case Management colleagues at HQ
Qualifications
Background Requirements
The incumbent must have a health, life science, or medical science degree or equivalent by education / experience.
He/she should have at a minimum 1 year of pharmaceutical industry experience.
He/she must have an awareness of Pharmacovigilance regulations within his/her assigned country(ies).
The PV Specialist is expected to have strong communication and time management skills and have the ability to work independently with minimal supervision.
Functional competencies
PV Intelligence
awareness of pharmacovigilance systems & requirements
awareness of pharmacovigilance principles, concepts, practices & standards
knowledge of the local country(ies) pharmacovigilance regulations & obligations
awareness of Good Clinical Practice concepts
Skills
Communication skills
excellent written & spoken English
ability to communicate effectively verbally and in writing
proficient in local language(s)
proficient in Good Documentation Practices
Computer skills
good word processing, presentation & spreadsheet application skills
familiar with the use of a safety database
ability to learn new computer interface systems
Personal
Strong project management skills with the ability to prioritise assignments
Excellent time management, organizational & planning skills
High level of accuracy & quality in work
Strong collaboration skills with the ability to work across boundaries
Sense of urgency and the ability to make rapid, disciplined decisions
Compliance mindset/focused
Courage and candor
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1