Pharmacovigilance & Regulatory Affairs Specialist

Job Description

The Position

Responsible for the Pharmacovigilance submission requirements and rest of activities, in addition to the Regulatory Affairs management for the assigned portfolio in Colombia according and in compliance to Organon policies and procedures as applicable. The Specialist is the regulatory contact with local stakeholders and headquarters and is the direct contact for health authority submission specific topics.

Responsibilities

• The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.
• Responsible for execution of local Pharmacovigilance and Regulatory Affairs processes and activities in alignment with Pharmacovigilance and Regulatory Affairs systems and their associated Quality Management System, following department Standard Operating Procedure, company Policies and Procedures and country legislation.
• Acts in full compliance with global and local Standard Operating Procedure and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions locally for non-compliance issues.
• Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality Pharmacovigilance and Regulatory Affairs data and evaluates processes for potential improvement in efficiency and effectiveness.
• Demonstrate knowledge of, and ensure compliance to, all relevant regulatory and pharmacovigilance legislation and internal procedures.
• Proactively identify procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
• Set quality standards, by participating in the development of appropriate SOPs and Work Instructions for affiliate activities such as submissions, license maintenance, agency interface, labeling, promotional review, pharmacovigilance and QA actions etc., per requirements of the internal policies and applicable local regulations.
• Maintain appropriate archive (electronic documentation or paper) to ensure that work is traceable and complies with all appropriate regulations.
• Ensure prescribing information, labels and other packaging components are in alignment with regulations and core safety information.
• Work on continuing improvements and simplification.
• Development and maintenance of a consolidation work plan and tracking system.

Regulatory Affairs:

• Responsible for all daily RA processes and activities within the countries covered by the country operation as required.
• Provide strategic input and regulatory support for timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards.
• Establish and maintain a strategic partnership through effective, timely, communication with Area Commercial, Medical and Regulatory for all products.
• Maintain product license in compliance with market supply, and local authority expectations. Ensure alignment with all applicable change control documents.
• Coordinate and assure a timely review and approval of the Artworks for packaging materials for all products.
• Support to Sales Department with Regulatory Documents (GMP certificates, Bioequivalence letters and others) for Tender Bids.
• Support the others regulatory process as required by the Manager.

Pharmacovigilance:

• Daily PV processes and activities within the country as required.
• Day-to-day adverse events case management including case intake and follow up activities in accordance with Global Pharmacovigilance procedures and country regulations.
• Ensure that the vendor performs the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs)
• Ensure the ICSR acknowledgments and reconciliation activities for pharmacovigilance cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) are managed and ensure processes the reports in accordance to local procedures/ pharmacovigilance legislations.
• Responsible for local preparation and submission to the Health Authority of the aggregate report in country.
• Supports local pharmacovigilance audits and inspections including readiness activities and supports other audits/inspections including the development of corrective actions and preventive actions in response to findings/observations.
• Provide support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable.
• Supports audits of contractual partners/vendors as necessary.
• Develop and maintain local PV controlled documents (i.e., SOPs, training materials) ensuring that they are kept current.
• Supports required training of the local company staff, distributors, vendors, business partners including training documentation (including maintenance of the local training matrix and onboarding plans).
• Responsible for ensuring PV language is included in local agreements, liaising with business partner as required, and ensuring maintenance of BDLM with respect to local and regional contracts.
• May be assigned responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures and ARMMs locally.
• Point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned).
• Liaise with the local business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight.
• Manage agency interface for safety and compliance issues.

Required Education, Experience and Skills

• +2 years in Regulatory Affairs and Pharmacovigilance at Pharmaceutical Industry.
• Good knowledge of ICH, GMP and local regulations.
• Language: Advanced/ Native Spanish
• Language: English (Reading, writing and speaking) –advanced level.
• Proficient in MS Office software.
• Attention to detail.
• Ability to work cross-functionally in pharmaceutical company environment.
• Time management.
• Good self-organization, creativity and initiative.
• Flexible
• Team-player
• Accurate
• Effective communication skills (both written and oral).
• Ability to transmit knowledge to others.

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Search Firm Representatives Please Read Carefully
Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID: R529058