Sr Pharmacovigilance Analyst

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

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Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for Sr Pharmacovigilance Analyst 

You will be responsible for:

• Ensuring that the LOC PV activities are 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.

• Plan and ensure timely submission of Aggregate Reports according to local regulations.

• Provide local data as required to support the preparation of Aggregate Safety Summary reports (PSUR, DSUR, etc.).

• Perform contract review and maintain oversight to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.

• Coordinate the provision of support for third party safety agreements with PV implications at the local level and ensure the PV agreement is implemented locally, as appropriate.

• Creation and implementation of business continuity plans (e.g. inspection readiness, AE reporting and coverage).

• Key responsibility is to ensure that systems and processes are available for collection (initial and follow-up), review, reporting and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.

• Manage and maintain active involvement in day-to-day AE reporting as applicable (case registry, compliance with global organization requirements).

• Accountable internally to ensure that the LOC meets procedural defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.

• Ensure PV inspection readiness on the LOC level, managing and with oversight of any non conformance and corrective/ preventive actions.

• Assist inspectors / auditors; support document requests.

• Take appropriate measures to ensure that new safety information is available to Health Care Professionals (HCP) in a timely manner, if applicable.

• Oversight responsibilities of case processing operational activities delegated to the Regional Pharmacovigilance Case Management hub for Latin America or external vendor as appropriate.

• Must have an appropriate system of PV and Risk Management in place in order to assure appropriate oversight for the implementation of Risk Management Activities for products o within its responsibility.

• Involvement in implementation of Risk Management Plans and Additional Risk Minimization Activities, if required.

• Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups of any changes to local laws and regulations regarding PV.

Qualifications / Requirements:

• Bachelor Degree Completed in health areas;

• Advanced English language is required (Spanish as a differential);

• Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field;

• General knowledge on healthcare and safety

• Proven ability to organize workflow activities and manage multiple critical issues;

• Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external stakeholders;

Other requirements

• Demonstrable knowledge of all local PV requirements and of global aspects of drug Safety

• Preferred experience in pharmacovigilance, not limited;

• By preference, a minimum of 3+ years pharmaceutical industry experience