Pharmacovigilance Senior Analyst

hace 6 meses

Capital Federal Buenos Aires, Argentina Johnson & Johnson A tiempo completo

Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

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**PROPOSITION**
- Ensuring that the Cluster 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.
- Supporting LSO and the Cluster on aspects of Pharmacovigilance
- Acts as Local Safety Designee in Argentina

**RESPONSABILITIES**

Case processing
- Maintain oversight in daily AE reporting activities ensuring compliance with local regulations and company procedures (monthly sampling for inbound and outbound compliance oversight, investigation on delays as required, reconciliation with vendors and partners as applicable)
- Oversight responsibilities of case processing operational activities delegated to the Regional Pharmacovigilance Case management hub for Latin America.

Translation
- PBRER, RMP, Health Authority (HA) correspondence, regulatory intelligence, as applicable (translation requests and purchase order management.

Contracts/Partners oversight
- Oversight of data generating activities to ensure any solicited information includes appropriate review and reporting process for potential AEs capture (ex. Patient support programs, market research, surveys, websites), as applicable.
- Contract oversight (verification of contract activities fulfilment)
- PSMF maintenance

Clinical trial compliance
- Close collaboration with GCO and MADU teams to have the proper AEs submission pathways defined.
- Ensure regulatory requirements are fulfilled in every cluster country collection activities are being conducted.

Submission to HA
- Ensure fulfillment of all regulatory requirements in a timely manner.
- PBRER: calendarization, preparation, submission and tracking of PBRER for each product in every country according to local requirements.
- RMP: analysis, decision making, preparation, submission and tracking of RMP for each product in every country according to local requirements.
- Responses to HA queries are performed in a timely manner.
- SSI/ESI: preparation, translation, submission and tracking of any safety communication as applicable

Risk Management
- Assure appropriate tracking and documentation for the implementation of Risk management activities.

Inspection & Audit support
- Work with the LSO in having the PV system in inspection readiness level at all times on the LOC.
- Assists inspectors/auditors; prepare support documents requests.
- Address follow up actions from findings; monitor non-LSO corrective actions derived from PV audits / inspections.

Collaborate & Support
- Collaborate with Regulatory affairs to comply with product strategy for submission and updates on the Marketing Authorization of each product, prepare and submission of safety related queries, as applicable.
- Collaborate with Medical affairs for review and approval of safety aspects of local study protocols, patient support programs to ensure appropriate safety reporting to GMS and HA, as required.
- Participate in the divestments, discontinuations, new launches change control management with CQ and Supply.
- Provide technical and strategic input and participate in projects led by the regional PV team and IVP work streams as applicable.

Safety training
- Ensure proper documentation of self-training on drug safety reporting responsibilities and maintenance of awareness of drug safety reporting in general.
- Provide on boarding training for new hires.
- Participate in vendor and distributor trainings.
- Follow up on annual training from the entire cluster.

Procedural document design
- Ensure proper implementation of global procedural documents and/or write, validate and implement local implementation memos (LIM) for regional / global procedures and verify adherence.
- Maintain local documents within the document management system.

Safety policy
- Be an expert on local regulation.
- Participate in new regulation local impact analysis

**Qualifications**:

- Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field;
- Medical or pharmaceutical sciences with proven expertise and experience in pharmaceutical regulations and R&D processes is preferred.
- By preference a minimum of 2 + years pharmaceutical industry experience with at least 1 year in a PV responsibility role
- Proven ability to organize workflow activities and manage multiple critical issues.
- Awareness of and familiarity with industry principles of PV, drug development and pharmacology
- Expert knowledge of Glo

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