Associate Medical Director, Pharmacovigilance

OBJECTIVE:

The Associate Medical Director serves as the Pharmacovigilance Physician for designated products, either as Global representative or as region back-up. Responsible for oversight of signal detection and risk management activities for designated global products. Ensure patient safety is adequately addressed in TGRD sponsored studies.



ACCOUNTABILITIES:

Perform activities required to serve as Global PV physician:

Act as PV GPT member and GPST member and lead the Safety Working Group

Review and oversight of all safety data, including non-clinical and clinical, for the product

Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities for the product globally.

Interactions with external experts and regulatory agencies

Review of safety data and participate in dose escalation decisions

Authorship and sign off of Safety Monitoring Plan/Risk Management Plan

Review or generation of monthly safety reports for signal detection

Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators.

Direct the set up of safety procedures and development of safety exchange agreements for co-development projects

Oversight of selection of members, set up and conduct of DSM activities.Perform activities required to serve as regional PV physician:

Review of all local cases for the designated products

Assist with activities related to local regulatory agency interactions if required

Working knowledge and familiarity with clinical protocols, SAPs, clinical study reports and periodic reports for the product.

Member of safety working group and participate in compilation and review of data to be used by the group.

Maintain professional knowledge and accreditation by active participation in continuing medical education activities.

REQUIREMENTS


EDUCATION, EXPERIENCE AND SKILLS:

Qualified physician (medical degree)

Minimum of 2 years experience in pharmacovigilance, clinical research or clinical development

1-2 years clinical experience with patients following post-graduate training with significant knowledge of general medicine.

Knowledge of principles of epidemiology and statistics.

Critical thinking and analytical skills and ability to make high level decisions

Excellent oral and written communication skills including ability to present to large internal/external groups Good level of computer literacy with Microsoft applications

LICENSES/CERTIFICATIONS:

US - Active US license preferredEU - registered to practice in the EU

TRAVEL REQUIREMENTS:Estimated 5-10 times per year including possible international travel.



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