Drug Safety Specialist

Drug Safety Specialist
Empresa:

(Confidencial)


Lugar:

Bogotá D. C.


Área:

Otros

Drug Safety Specialist

Detalles de la oferta

Bogotá, Cundinamarca

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Pharmacovigilance Specialist is responsible for the day-to-day case management activities within the country(ies) covered by the country operation or Regional PV LATAM HUB, including compliance with PV processes and regulations and our policies and procedures and is able to function independently in the processing of adverse events.
Procedural responsibilities include the areas of: Adverse experience case management, including HA submissions; aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and aggregate safety reports.

Your responsibilities

- Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation, including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per our procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.

- Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.

- Responsible for the reconciliation of adverse events reports received from other operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.

- Responsible for the filing, storage and archiving of safety-related data in accordance with our policies and local requirements.

- Serve as the local Deputy Qualified Person for PV (QPPV) / deputy local responsible PV person for the country(ies) when delegated by PV Country Lead.

- Serve as back-up in the absence of the PV Country Lead to ensure business continuity. Responsible for being compliant with local PV regulations, our policies and procedures and Global Safety procedures at the country level.

- Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.

- Prepare for audits/inspections for their country/territories and participate in the audit and/or inspection.

- Identify and communicate potential safety issues to PV Country Lead.

- Deliver training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors /business partners in the country(ies) within scope.

- Train and mentor PV staff, if applicable

- Complete and document required PV training within the required timelines.

Background Requirements

- The Pharmacovigilance Specialist must have a health, life science, or medical science degree or equivalent by education / experience (i.e Nurse, Pharmacist, Biologist, Bacteriologist, Microbiologist,)

- He/she should have at a minimum 1 year of pharmaceutical industry experience preferably pharmacovigilance, regulatory and clinical trials. The PV Specialist is expected to have strong communication and time management skills, and have the ability to work independently with minimal supervision.

Pharmacovigilance Experience

- Awareness of pharmacovigilance systems & requirement

- Awareness of pharmacovigilance principles, concepts, practices & standards

- Awareness on Adverse events and PV reportable information for case management

- Awareness of Good Clinical Practice concepts and Quality Management systems

- Awareness of LATAM pharmacovigilance regulation to perform submission to LATAM HAs

Skills

- Communication skills

- Excellent written & spoken English

- Ability to communicate effectively verbally and in writing

- Proficient in Good Documentation Practices

Computer skills

- Good word processing, presentation & Excel application skills

- Familiar with the use of a safety database

- Ability to learn new computer interface systems

Personal

- Strong ability to prioritize assignments

- Work under pressure and tight due dates

- Excellent time management, organizational & planning skills

- High level of accuracy & quality in work

- Strong collaboration skills with the ability to work across boundaries

- Sense of urgency and the ability to make rapid, disciplined decisions

- Compliance mindset/focused

- Courage and candor

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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.

Employee Status:

Temporary (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R53157


Fuente: Kitempleo


Área:

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