Pharmacovigilance (PV) Specialist Job

Date: Feb 11, 2019

Location: Istanbul, TR

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Requisition ID: DRU000946

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) 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 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.


Qualifications

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 candor

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. 

If you need an accommodation for the application process please email us at staffingaadar@MSD.com. 




Job: Drug/Dvcs Sfty Survnce (NonMD)
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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