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Pharmacovigilance Specialist Job

Date: Nov 3, 2017

Location: Sweden, SE

Company: MSD

Requisition ID: DRU000717

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.

Our new offices in Stockholm offer a fun, collaborative, innovative environment where you can interact with team members easily and find the right work environment “zone” to suit your needs.

We are seeking a motivated Pharmacovigilance Specialist to join our growing Pharmacovigilance Department in MSD’s Stockholm office. The opportunity is a full time (100%) on a permanent contract.
The PV-Specialist will be responsible for the day-to-day case management activities in Sweden, including compliance with PV processes/regulations, corporate policies and procedures, as well as the independent processing of adverse events. Where needed you will manage communication with the local authorities and internal stakeholders. The position reports to the PV Country Lead.

We look for people who are able to function independently in the processing of adverse events. This includes the following responsibilities:

• Responsible for day-to-day adverse experience case management including case intake and follow-up activities
• Responsible for aggregate safety report submissions
• Responsible for the reconciliation of adverse events reports received from e.g., Designated Point of Contact, Medical Information, and contractual partners, as applicable
• Responsible for the filing, storage and archiving of safety-related data
• Assist in preparation and participate in audits/inspections
• Assist in the delivery of pharmacovigilance training to PV staff and customer facing non PV staff
• Work pro-actively with quality and continuously improve work processes within PV; implementation of new or update of local SOP’s
• Cross-functional collaboration with .e.g. Regulatory Affairs, Quality Assurance, Medical Affairs


Education / Experience:
• University degree in healthcare / life science / pharmacy / medical science (or equivalent education / experience).
• At least 2 years of pharmaceutical industry experience is required, working with pharmacovigilance.
However, people with experience in medical information, quality assurance, regulatory affairs or clinical trials may also be of interest for this position
• Good understanding of Pharmacovigilance regulations in Sweden as well as pharmacovigilance practices and standards; awareness of Pharmacovigilance systems
• Experience working with Vaccines would be an asset (but not a requirement for the role)
• Compliance mindset/focused, high level of accuracy and quality in work Compliance mindset/focused, high level of accuracy and quality in work
• Proven ability to work independently with minimal supervision

Communication skills:
• Excellent written & spoken Swedish and English
• Ability to communicate effectively verbally and in writing
• 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

• 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

Job: Drug/Dvcs Sfty Survnce (NonMD)
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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