Pharmacovigilance

AGGREGATE REPORTING

• Review, translate (if applicable), prepare, submit and track aggregate reports as required by local regulations
  and ensure compliance oversight requirements are met

• Support the preparation of aggregate reports and provide due dates to Global Medical Safety (GMS) and
  promoting synchronization with the Global Aggregate reporting schedule,
  in accordance with local regulatory requirements and in collaboration with the local Regulatory Affairs unit.

LOCAL REGULATORY REQUIREMENTS

• Ensure awareness of new/changes in local PV regulations and evaluation of the impact on
  local/global processes and notification of appropriate local, regional and global groups

• Perform procedural document impact assessment and support implementation of
  Global PV relevant Procedural Documents, as applicable

• Implement new or updated PV regulations, as needed

• Provide input into requests for information in support of the development of LMS-wide processes, systems,
   and policies

• Engage in local industry associations and drive local policy shaping initiatives based on One J&J Voice.

PHARMACOVIGILANCE SERVICE PROVISION

• Ensure that day-to-day PV activities and safety activities for medicinal and non-medicinal products
   (i.e., medical devices) are performed satisfactorily.

• Collaborate with the local Marketing Authorization Holder (MAH) to enable fulfilment of its regulatory
  responsibilities and meet their business objectives

• Manage and implement local Pharmacovigilance Agreement (PVA’s)

• Support activity owners in including appropriate PV language in vendor contracts to ensure safety obligations
   are met as applicable

• Provide timely and accurate EU Pharmacovigilance System Master File (PSMF) contributions and ensure
  adequate process is established for the implementation and the maintenance of the local “PSMF”, as applicable

• Ensure proper handling of Health Authority (HA) safety related queries
   (communication, response, and escalation).

• Communicate with the HA, when applicable, to clarify requirements in support of LMS-wide policy,
  process harmonization/improvement

• Ensure business continuity to safeguard compliance

• Provide support to the Related Research Activities Center of Excellence  (RRA CoE)
   for local Related Research Activities (RRA).

• Collaborate with project owners and LMS operations to provide input for the reporting process of potential AEs
   included in local data generating activities to ensure appropriate safety monitoring

LOCAL BENEFIT-RISK ACTIVITIES

Medical Insights

• Establish Product knowledge with focus on safety profiles, Therapeutic Area (TA) and
   Disease Pathway knowledge, supporting the needs of the local Medical and Commercial organization,
   in collaboration with the Risk Management Leads and LMS product team as applicable.

• Participate in the TA and Product local cross-functional teams to contribute safety insight for
   strategy development, act as a safety expert in team meetings, communicate relevant safety information for
   LOC stakeholders and perform training on safety relevant aspects, as appropriate

• Participate in LMS product teams as applicable.

Local Product Compliance Related Activities

• Conduct the local product compliance related activities in collaboration with stakeholders such as
   Medical Safety Officers (MSO) as needed.

• Communicate new relevant safety information available in a timely manner to GMS and to LOC stakeholders
   as per procedure

• Involvement in local safety signal detection, if applicable

• Support internal discussion of Risk Management Plans (RMPs)/ Addendums with local stakeholders,
   participate in local implementation of RMP including additional risk minimization activities and
   negotiate with local HA to reach agreement, etc., as applicable

• Prepare local RMP/Addendums based on internal alignment and local/global procedures as required

• Support implementation of Company Core Data Sheet (CCDS) into local label
   (Summary of Product Characteristics (SmPC),patient Leaflet etc) as applicable.

TRAINING

• Support global roll out AE/PQC training in LOC

• Provide safety training to maintain awareness of safety reporting as required

• Manage AE/PQC training to distributors/vendors and translation of AE/PQC training material, where needed

Minimum Qualification

• A degree in life, health or pharmaceutical sciences is preferred, proficiency in Medical terminology

• Excellent verbal and written communication skills

• Fluency in the national language(s) and the English language required

• Ability to effectively communicate and negotiate with internal and external customers.
  Ability to establish and maintain relationships within the organization and with authorities

• Excellent analytical skills to identify gaps and root causes of issues and think out of the box to
   develop a solution.

• Excellent computer proficiency e.g MS Office, 

• Proficiency in global and local Standard Operating Procedures (SOPs)

• Must be able to work independently with minimum supervision while meeting tight deadlines

• People leadership experience (for people manager) is preferred

Experience

By preference a minimum of 2 + years pharmaceutical industry experience or/ with at least 1 year in a product vigilance responsibility role or a related GxP-regulated role.

Required Skills:

Preferred Skills:

Analytical Reasoning, Clinical Operations, Coaching, Collaboration, Cross-Functional Collaboration, Detail-Oriented, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy