Job Description
The Position
The Specialist PV ICSR Unit is responsible for managing activities related to the processing of pharmacovigilance (PV) and technovigilance (TV) cases (and other vigilances) covered by the ICSR Unit.
He or she participates in the continuous improvement of PV/TV processes/activities and collaborates with colleagues to ensure compliance with local laws and regulations, including ensuring the continuity of PV/TV activities.
The Specialist may serve as deputy Subject Matter Expert (SME) for certain PV/TV activities (as delegated/assigned by the ICSR Unit Lead) which may include but are not limited to: case management and literature processes, compliance activities, training and maintenance of procedural documents, and/or special projects.
Responsibilities
- Ensuring the processing of PV cases and other vigilance, from all sources, in compliance with the deadlines required by the regulations and procedures in force under the responsibility of the ICSR Unit Lead.
- Participating in the monitoring of potential sources of PV data and other vigilance
- Participating in the continuous improvement of PV/TV processes/activities and monitoring of service compliance
- Execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following Organon SOPs, company Policies and Procedures and country legislation
For PV case processing activities and other vigilance, the Specialist PV:
- Ensures the reception and sorting of emails from the generic mailbox of the PV ICSR Unit team
- Identifies PV cases or other vigilance for processing
- Acknowledges receipt to the notifier of the PV case or other vigilance
- Performs the search for duplicates
- Enters PV cases and other vigilance in the local database
- Performs quality control of PV cases and other vigilance in the local database
- Transmits PV cases and other vigilance to the global database or to partners according to the internal requirements and respective Agreements in force
- Ensures the anonymization of source documents and their recording and archiving if applicable
- Performs documentation attempts (FU) of cases with reporters if applicable
- Responds to requests for clarification and/or translation requested
For PV case source management activities and other vigilance, Specialist PV:
- Performs periodic reconciliations of Pharmacovigilance data from PV case sources and other vigilance
For continuous improvement activities of PV processes/activities and monitoring of service compliance, the Specialist PV:
- Checks the assessment of the severity criterion and the proper management of information in the global case database
- Ensures compliance with submission deadlines to the competent authorities
- Acts in full compliance with global, local procedures and regulations in force
- Contributes to the identification and management of deviations and contributes to the implementation and monitoring of CAPA
- Participates in the drafting and implementation of quality documents
- Participates in the department's compliance monitoring activities
- Participates and helps with local and/or global audits and inspections including support in development and implementation of CAPAs in response to deviations.
- Participates in the continuity of PV activities and ensures permanence if necessary
- Good general knowledge of pharmacovigilance/technovigilance regulations and general processes of a PV system and expertise in activities related to PV case management.
- Good time management, organizational, rigor, task prioritization and problem-solving skills.
- Ability to be open and flexible to new ideas and demonstrate curiosity about new work approaches.
- Apply the changes in activity that are requested and know how to adapt to new approaches, changes in priorities, responsibilities and projects.
Qualifications
- Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals.
- Communication Skills: Demonstrates strong communications skills to convey and receive information in English and local language. Demonstrates advanced oral and written communications skills. Demonstrates good presentation skills.
- Problem Solving: Demonstrates skills in problem solving using creative thinking, gathers data from appropriate stakeholders and ability to respond to new complex situations and influence organization direction.
- Strategic Thinking: Demonstrates strong skills to drive change that enhances processes within the company or cross-functionally within MRL/MMD/GHH that improve quality and /or add value to the business.
- Project Management: Demonstrates strong skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV activities in accordance with timelines and appropriate regulations.
- Regulatory and Compliance Management: Demonstrates knowledge of PV/TV regulations and regulatory trends
Required Education, Experience
- He/she should have a minimum of 2 years of industry experience in pharmacovigilance.
- The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) and Nordic language (written).
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
Regular
Relocation:
No relocation
VISA Sponsorship
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Shift
Flexible Work Arrangements:
Valid Driving License
Hazardous Material(s):
Number Of Openings
1
Requisition ID:R533791
