Job Description
The Specialist PV Unit is responsible for supporting activities related to the vigilance originating from the unit, participates in the continuous improvement of Pharmacovigilance (PV)/Technovigilance (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 Unit Lead) which may include but are not limited to: compliance activities, training and maintenance of procedural documents, audits and inspections including related readiness activities, Aggregate Reports and Risk Management activities, Safety Data Source topics, PSMF activities, BP and vendor management, Business Continuity in Pharmacovigilance/Techno vigilance, Safety Signal management, medical devices and/or special projects.
Responsibilities
- The Specialist PV:
- Serves as Local PV responsible (PVR) as required per local PV legislation.
- Participates in the monitoring of potential sources of PV/TV data and other vigilance.
- Participates in the continuous improvement of PV/TV processes/activities and monitoring of service compliance.
- Executes of local PV/TV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation.
- Supports 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 Unit.
For PV case source monitoring and management activities and other vigilance, Specialist PV:
- Ensures the reception and sorting of emails from the generic mailbox of the PV Unit team.
- Participates in the implementation of processes for the management and monitoring of PV/TV data sources (Medical Information, Literature Monitoring, market studies, clinical studies and non-interventional studies, Digital Media, etc.)
For continuous improvement activities of PV/TV processes/activities and monitoring of service compliance, the Specialist PV:
- Acts in full compliance with global, local/unit 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 and develops compliance and performance indicators.
- 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 training of company employees, distributors, subcontractors, business partners, including training documentation.
- Supervises and coordinates activities delegated to service providers according to contractual terms.
- Participates in the continuity of PV/TV activities and ensures permanence if necessary.
For PV case processing and other vigilance, the Specialist PV may support in:
- Identifying 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.
- Performs periodic reconciliations of Pharmacovigilance data from PV case sources and other vigilance.
Required Education, Experience And Skills
- Good general knowledge of pharmacovigilance/techno vigilance regulations and general processes of a PV system.
- 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.
Preferred Education, Experience And Skills
- 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) while proficient in local language.
- 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.
- Decision Making: Demonstrates skills to utilize knowledge, networks and data to make rapid and appropriate decisions with some management oversight and to determine when escalation of issues is necessary.
- Business Operations/Knowledge of Field: Demonstrates knowledge of business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.
- Regulatory and Compliance Management: Demonstrates knowledge of PV/TV regulations and regulatory trends.
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:R533033
