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IPV Affairs PVRR Associate Manager - 2406212886W

Description

Description

The IPV Affairs PVRR Associate Manager will support the Global IPV Affairs Team in all IPV operations and compliance tasks related to the vigilance of the J&J product portfolio under the umbrella of International Pharmacovigilance (IPV). The IPV Affairs PVRR Associate Manager will work in close partnership with Regional Heads, Local Safety Teams, and Case Management Team, to ensure adequate centralization of activities enabling process optimization and increasing efficiencies. He/She will ensure a consistent operations approach across the regions in alignment with the Global Medical Safety (GMS) and Global Medical Organization (GMO) processes for areas of responsibility. He/She in partnership with IPV Affairs Project Lead, will also lead or participate in global or regional multi-disciplinary projects and shape strategies for the projects assigned.

Key Responsibilities:

General

• Serve as a Member of the Global IPV Affairs Team

• Be an ambassador of the Office of the Chief Medical Officer (OCMO) culture and vision

• For areas under responsibility, act as Subject Matter Expert for the IPV organization, drive and/or support on finding most suitable and efficient solutions during discussions with different cross functional teams and collaborate on reviewing and streamlining applicable procedural documents Support IPV organization on applicable operational tasks and ensure overall inspection readiness across IPV

• Work in close partnership with IPV Affairs members across regions to ensure a global consistent approach for IPV

IPV Project Management

• Lead and/or participate as specialized function in regional or global projects for areas of expertise to streamline and optimize PV operations.

PV Regulatory Requirements

• Work with the Regional heads and the Local Safety Officers to maintain oversight of changes in regulatory compliance regulations

• Support the analysis, impact assessments and documentation of PV compliance processes, translating new/revised requirements into new or amended regional/global IPV processes

• Keep oversight and monitor compliance of local implementation of activities related w/ new/revised PV legislation identified at local level

Qualifications

EDUCATION & EXPERIENCE REQUIREMENTS:

• Medical, pharmaceutical or nature science degree with proven expertise and experience in pharmaceutical industry and experience in Pharmacovigilance

• Minimum of 2 years’ experience in a position within Pharmacovigilance

• Task-oriented with proven experience in the delivery of high-quality work and as part of a multi-disciplinary team

• In-depth understanding of vigilance systems and processes; knowledge of or experience with International Pharmacovigilance and compliance regulations and guidelines is an advantage for this role

• Demonstrable insight to the development of regulatory requirements with knowledge of Global aspects of drug/devices safety, including international reporting requirements and relevant country-specific variations within the region.

• Experience in training/mentoring team members is preferred

• Excellent computer-based application skills

• Fluent communication skills in English, any additional language is a plus

Location & Travel

• Global Office based role from any J&J Innovative Medicine in the correspondent region. Up to 10 % travel might be required

Primary Location Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss

Other Locations Europe/Middle East/Africa-France-Île-de-France-Paris, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Egypt-Cairo-Cairo, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, Europe/Middle East/Africa-Spain-Av. Parten-n, 16-Madrid, Europe/Middle East/Africa-United Arab Emirates-Dubai-Dubai, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Portugal-Lisbon-Lisbon

Organization Janssen-Cilag Germany (8000)

Job Function Drug & Product Safety Operations

Req ID: 2406212886W