Asociado De Farmacovigilancia Ii jobs at Teva in Mexico, Mexico City

1. Analysis of stability samples & working standard qualification activity as per defined procedure & monograph.
2. Maintaining a set of procedure supporting to ATS department for (GMP & GLP) techniques implementation.
3. Maintaining a system of methods and specification for all materials and products.
4. Data filling and maintaining the log books, certificate, stability report and stability data in archive.
5. Monitoring of stability studies with respect to ICH Q-1 and conducting analytical method validation activity according to ICH Q-2.
6. To initiate the LIR / OOS if any procedural gap related with SOP / monograph during routine activity.
7. Qualifications of all analytical instruments should be maintained in stability Section.
8. Follow the defined safety procedure during day to day activity in laboratory.
9. Any other job assigned by Manager Quality Control.

Bachelor/Master of Science/ B. Pharmacy

One Years Experience

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Ensure the effective operations of the US Generics Commercial and Sales Team.
• Coordinate corporate business reporting for US Generics, including gathering information and preparing presentations for Quarterly Business Reviews, Investor Relations earnings calls, and other related forums.
• Aid in preparation and coordination of financial planning and reporting, including AOP, LBE and LRP cycles.
• Leading of special projects and representing US Generics interests via collaborations with other NA Commercial teams.
• Assist with coordination of industry events, conventions, top-to-top meetings, and other forums where customer-facing information and high level of event coordination is necessary.
• Other duties and special projects as assigned.
  

• Bachelor's Degree is required. MBA or advanced degree preferred.
• A minimum of 5 years US generics pharmaceutical industry experience or equivalent in various commercial or related roles required
• Excellent communication skills with expertise in PowerPoint and Excel required
• Demonstrated broad knowledge of the generics pharmaceutical industry, including understanding of the products and customers
• Understanding of sales forecasting process
• Demonstrated experience working with multiple levels of an organization
• Understanding of various commercial functions, including customer landscape, pricing, product marketing, customer service, forecasting, and new products
• Demonstrated leadership experience is strongly preferred

Skills/Knowledge/Abilities:

• Strong Microsoft Office skills including PowerPoint and excel
• Communication skills
• Multitasking
• Qlik Sense, Tableau etc.
• Attention to detail
• Time management
• Teamwork
• Problem solving skills

Travel Requirements:
Approximately 5% domestic travel throughout the US.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Review and confirm that accurate written records of all PV related activities are created, organized and maintained in accordance with all applicable global and local Standard Operating Procedures (SOPs), local Work Instructions (WIs) and ensure they are updated as required by regulations.

• Responsible for the receipt of adverse event information, including XMLs extraction, upload and receipt.
• Performs case registration of adverse event reports by entering search information.
• Responsible for submitting adverse event information to licensed partners within the required timeframe as per the pharmacovigilance agreement.
• Responsible for collecting additional information from reporters and following up with healthcare professionals and consumers.
• Review and assessment of the reportability of the adverse event to FDA or Health Canada, as appropriate.
• Responsible for receiving, reviewing and performing all necessary actions related to negative acknowledgements to FDA and Health Canada, as appropriate.

Pharmacovigilance QMS

PhV Reconciliation

- Bachelor of Science degree with a major in a life science (e.g., pharmacy, physiology, biochemistry, anatomy, pharmacology, microbiology) at least
- 3 to 5 years experience in health or pharmaceutical sector and at least 2 years of experience in Pharmacovigilance
- Advanced English
- MS Word, MS Excel, MS Powerpoint, MS Outlook. Knowledge of computer systems such as Veeva Vault, ArisG, Argus and Cognos is a plus.
- Comfort with PV IT systems and familiarity with Veeva Vault security database and medical terminology.
- Knowledge of related FDA/Health Canada and international regulations.

Sr Manager Pharmacovigilance

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.