Merck Sharp & Dohme

Pharmacovigilance Specialist

Background Requirements
The incumbent must have a pharmacy, health, life science, or medical science degree or equivalent by education / experience. He/she should have at a minimum 1 year of pharmaceutical industry/pharmacovigilance 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 candorThe 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 Merck/MSD 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.