Johnson & Johnson Careers
Capital Federal, Argentina
Requisition ID: 8193190624
If you're passionate about your career every single day, we'd love to hear from you!
We invite you to read this Job Description and apply if you are passionate about the position and meet the requirements.
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, irritable bowel disease and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), cardiovascular and metabolic diseases (e.g., diabetes) and Pulmonary Arterial Hypertension (PAH) and Rare Diseases.
Pharmacovigilance Coordinator will be responsible:
1. Ensuring that the activities are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners.
2. Having an appropriate system of Pharmacovigilance and Risk Management in place in order to assure appropriate oversight for products within its responsibility.
3. Perform contract review and maintain oversight to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
4. Coordinate the provision of support for third party safety agreements with Pharmacovigilance implications at the local level and ensure the Pharmacovigilance agreement is implemented locally, as
5. Oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential Adverse Events (e.g.
patient support programs, market research surveys, internet sites), as applicable.
6. Assure the all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
7. Safety oversight of clinical projects conducted in the territory as applicable.
8. Perform contract review and maintain oversight to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
9. Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local Regulatory Authorities to the appropriate global and regional groups as
10. Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs to ensure appropriate safety reporting to GMS or appropriate case management centre and RAs, as required.
11. Participate in the Product Issue Management teams, as appropriate.
1. Education level required: Medical or pharmaceutical sciences with confirmed expertise and experience in pharmaceutical regulations processes are preferred.
2. Years of Experience: By preference a minimum of 3 + years pharmaceutical industry experience in a Pharmacovigilance responsibility role.
3. Required knowledge: knowledge of general medicine or pharmacy and clinical practice, or meaningful scientific/medical field; Awareness of and familiarity with industry principles of PV, drug development and pharmacology; Knowledge of Global, Regional and Local PV Procedural Documents as
4. Required skills: Proven ability to organise workflow activities and lead multiple critical issues. Excellent verbal and written communication skills with confirmed ability to negotiate and communicate with internal and external customers.
5. Language: Fluency in the national language(s) and the English language is required.
6. Location of the role: Belgrano, Buenos Aires.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies.
Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success.
We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
We are proud to be an equal opportunity employer.
Argentina-Buenos Aires-Capital Federal-Mendoza 1259
Janssen Cilag Farmaceutica Srl (fka Pharma Farmace (7425)