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Position Summary :
The incumbent is responsible for supporting Pharmacovigilance-related
activities in the JENA region and as required by Marketing Authorization
Holders (MAH) and/or study sponsors, as applicable. Also, will ensure the
maintenance of an appropriate PV, vigilance system, and Risk Management to
assure appropriate oversight for products within its responsibilities.
Main responsibilities:
Local Medical Safety Responsibility & Benefit Risk Management:
* Establish Product knowledge with a focus on safety profiles, Therapeutic Areas, and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Country Safety team lead (CSTL)/Local Safety Officer (LSO) if applicable.
Aggregate reports:
- Work with LSO to provide medical input and insights for aggregate reports while undertaking a local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs), as applicable.
Pharmacovigilance-Safety training support:
- Support LSO in the preparation of Pharmacovigilance training for Local Operating Company employees, and Adverse Event and Product Quality Complaints (AE/PQC) training to distributors/vendors and with the translation of AE/PQC material, where needed.
PV contract management:
- Support LSO with the local Pharmacovigilance Agreements (PVAs) preparation and implementation, including Local Safety Unit (LSU) training and adherence to PVAs,
- Coordinate the provision of support for third-party safety agreements locally e.g. local Vendor Agreements as necessary, and seek support from central functions like PV Service and Technical Contracts Group and International PV(IPV) Affairs as needed.
Safety regulations:
- Escort CSTL/LSO in detecting and reporting PV regulatory requirements for MAH,
- Support in the review of new/revised safety regulations (for drugs non-medicinal products & Medical Devices in the scope of responsibilities), the impact on the local processes, and notification of appropriate global and regional groups via the central PV policy tracker (new requirements and or updates).
Local Safety compliance (PV and non-medicinal product safety) :
- Provide insights on metrics to CSTL/LSO
- Support LSO with CAPA implementation, procedural document review from Subject Matter Experts and Area leads - depending on the topic
- Support in Impact assessments and action as required on a local level
- Provide content to the Pharmacovigilance System Master File (PSMF) contributions and data, as required, accurately and in a timely manner.
Pharmacovigilance and Vigilance Service Provision:
- Collaborate with CSTL/LSO to ensure that day-to-day Pharmacovigilance and safety activities for non-medicinal products (i.e. cosmetics, medical devices, commodities, nutritional's) are performed satisfactorily, and that full regulatory compliance is maintained at the Local Operating Company level including adequate record management.
Qualifications
Job Requirements
Qualification & Experience
* Minimum of 1-2 years experience in a healthcare compliance role or similar
* Bachelor's degree in life science/ pharmacy preferred
* proficiency in Medical terminology (local languages)
Knowledge & Skills
- Good verbal and written communication skills, fluency in local language(s) and English language required
- Good in data analysis and reporting
- Proficiency in global and local SOPs
- Ability to negotiate and communicate with internal and external customers.
- Ability to establish and maintain open relationships within the organization and with authorities.
- Ability to manage multiple critical issues and work under pressure
We will ensure that individuals with disabilities are provided reasonable
accommodation to participate in the job application or interview process, to
perform essential job functions, and to receive other benefits and privileges
of employment. Please contact us to request accommodation.
Johnson & Johnson Family of Companies are equal opportunity employers, and all
qualified applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity, genetic
information, national origin, protected veteran status, disability status, or
any other characteristic protected by law.